Paul-Ehrlich-Institut

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Our In­volve­ment in the CHMP

The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA) is responsible for the scientific assessment of the application dossier on the quality, safety and efficacy, including environmental safety, of a new medicinal product for human use as part of the centralised marketing authorisation procedure. The CHMP's scientific assessment report forms the basis for the European Commission's decision to grant or refuse a centralised marketing authorisation for the medicinal product for human use in all EU Member States.

The members of the CHMP are the scientific medicines experts from the national competent authorities in the EU Member States. Each Member State has one representative on the CHMP, and a further five members are co-opted on the basis of their particular expertise. The Paul-Ehrlich-Institut is represented as a co-opted member:

Dr Jan Müller-Berghaus (Source: T. Jansen/Paul-Ehrlich-Institut)

Dr Jan Müller-Berghaus, Paul-Ehrlich-Institut
Co-opted Member in the CHMP

2024

CHMP Meeting Highlights February 2024

New Medicines Recommended for Authorisation

  • Two products for the active immunisation against H5N1 subtype of influenza A virus received a positive opinion this month:

    • Celldemic (zoonotic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted, prepared in cell cultures)) received a positive opinion for the active immunisation against H5N1 subtype of Influenza A virus in adults and infants from 6 months of age and above.
    • Incellipan (pandemic influenza vaccine (H5N1) (surface antigen, inactivated, adjuvanted, prepared in cell cultures)) received a positive opinion for the active immunisation against influenza in an officially declared pandemic.

    Both products are identical, but are intended to target different applications (zoonotic vs. pandemic vaccine).
    Influenza subtype H5N1 is a zoonotic virus, which primarily occurs in birds (“bird flu”) and can be transmitted to humans. Pandemic influenza outbreaks can occur when a new highly infectious virus strain enters a population with low immunity from previous exposure. Infection with influenza virus usually occurs by droplet spread from infected people to uninfected people through inhalation. The viral infection can cause fever, cough and breathing problems up to pneumonia in humans. Although human transmission of H5N1 is rare, the mortality rate from H5N1 infection is high.

  • Tizveni (tislelizumab) has received a positive opinion for the following indications:

    • Tizveni in combination with pemetrexed and platinum-containing chemotherapy is indicated for the first-line treatment of adult patients with non-squamous non-small cell lung cancer whose tumours have PD-L1 expression on ≥ 50 % of tumour cells with no EGFR or ALK positive mutations and who have locally advanced non-small cell lung cancer (NSCLC) and are not candidates for surgical resection or platinum-based chemoradiation; or have metastatic NSCLC.
    • Tizveni in combination with carboplatin and either paclitaxel or nab-paclitaxel is indicated for the first-line treatment of adult patients with squamous non-small cell lung cancer who have locally advanced NSCLC and are not candidates for surgical resection or platinum-based chemoradiation; or have metastatic NSCLC.
    • Tizveni as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer after prior platinum-based therapy. Patients with EGFR mutant or ALK positive NSCLC should also have received targeted therapies before receiving tislelizumab.

    NSCLC is a serious and often fatal disease that accounts for 80 to 85 % of all lung cancers. A significant number of patients present with driver mutations in oncogenes, some of which can be aimed at by targeted therapies. Patients without known driver mutations need broader-acting therapies.
    Tislelizumab is a checkpoint inhibitor, targeting PD-1 (programmed cell death protein 1) on immune cells. Many cancer cells express a PD-1 ligand. Since activation of PD-1 down-regulates the immune system, blocking of the interaction between PD-1 and PD-L1 enhances the T cell responses against the cancer cells. Furthermore, tislelizumab was engineered to reduce Fc-mediated effector protein bindings, thereby reducing the antibody- and complement-dependent cytotoxicity.

  • Zynyz (retifanlimab) has received a positive opinion for the first-line treatment, as monotherapy, of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC) not amenable to curative surgery or radiation therapy.
    MCC is a rare, aggressive malignancy of the skin with a poor outcome when advanced. The carcinoma originates predominantly on light-exposed parts of the skin. The disease primarily affects old and/or immunosuppressed patients.
    Like Tizveni/tislelizumab (see information above), retifanlimab is also a checkpoint inhibitor targeting PD-1.

Recommendations on Extensions of Therapeutic Indication

  • Carvykti (ciltacabtagene autoleucel): extension of indication to include treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least one prior therapy, including an immunomodulatory agent and a proteasome inhibitor and have demonstrated disease progression on the last therapy, and are refractory to lenalidomide.
    Carvykti is already authorised for a later line of treatment of multiple myeloma.
  • Keytruda (pembrolizumab): extension of indication to include Keytruda, in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment, for the treatment of resectable non‑small cell lung carcinoma (NSCLC) at high risk of recurrence in adults.
    Keytruda is already authorised for the treatment of various types of solid cancer, including NSCLC in different therapeutic settings and lines of therapy.

CHMP Meeting Highlights January 2024

Recommendations on Extensions of Therapeutic Indication

  • Abecma (idecabtagene vicleucel): extension of indication to include treatment of adult patients with relapsed and refractory multiple myeloma (RRMM) who have received at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.
    Abecma is already authorised for a later line of treatment of RRMM.
  • Prevenar 20 / previously Apexxnar (pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed)): extension of indication to include the active immunisation for the prevention of invasive disease, pneumonia, and acute otitis media caused by Streptococcus pneumoniae in infants, children, and adolescents from 6 weeks to less than 18 years of age.
    Prevenar 20 / Apexxnar is already authorised for the active immunisation of adults.

Newly published EPARs

The EPAR – the European Public Assessment Report – is the main document where the EMA publishes the detailed information from the medicines assessed by the CHMP.

  • Elrexfio (elranatamab) is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.

Recently Started Marketing Authorisation Procedure

Every month, new medicinal products are submitted to the EMA for marketing authorisation, with the aim of providing patients with new treatment options for various diseases. The CHMP carries out a scientific assessment of the applications and makes a recommendation.

Initial marketing authorisation application:

  • Mirvetuximab soravtansine – Orphan medicine – treatment of ovarian, fallopian tube, or primary peritoneal cancer
  • Marstacimab – Orphan medicine – is indicated for routine prophylaxis of bleeding episodes in patients with haemophilia A or haemophilia B

2023

CHMP Meeting Highlights December 2023

New Medicines Recommended for Authorisation

  • Casgevy (exagamglogene autotemcel) received a positive opinion, recommending the granting of a conditional marketing authorisation (CMA) for the treatment of transfusion-dependent β-thalassemia (TDT) and sickle cell disease (SCD). The full indication is:

    • β-thalassemia: Casgevy is indicated for the treatment of transfusion-dependent β-thalassemia (TDT) in patients 12 years of age and older for whom haematopoietic stem cell (HSC) transplantation is appropriate and a human leukocyte antigen (HLA)-matched related HSC donor is not available.
    • Sickle cell disease: Casgevy is indicated for the treatment of severe sickle cell disease (SCD) in patients 12 years of age and older with recurrent vaso-occlusive crises (VOCs) for whom haematopoietic stem cell (HSC) transplantation is appropriate and a human leukocyte antigen (HLA)-matched related HSC donor is not available.

    β-thalassemia and sickle cell disease are two inherited disorders of the red blood cells. Different mutations lead to impaired production of haemoglobin and thus, to problems in red blood cell function. Casgevy is a cellular therapy, consisting of the patient’s own haematopoietic stem cells which are genetically modified to foster normal gene expression in red blood cells. Casgevy needs to be administered only once.

Recommendations on Extensions of Therapeutic Indication

  • HyQvia (human normal immunoglobulin): extension of indication to include HyQvia as an immunomodulatory therapy in adults, children and adolescents (0 to 18 years) in chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy after stabilisation with IVIg.
    HyQvia is already authorised as a replacement therapy in patients with primary and secondary immunodeficiency syndromes
  • VeraSeal (human fibrinogen / human thrombin): extension of indication to include the supportive treatment in children of all age groups where standard surgical techniques are insufficient:

    • for improvement of haemostasis,
    • as suture support: in vascular surgery.

    VeraSeal is already authorised for the treatment of adult patients in the same indications.

  • Zinplava (bezlotoxumab): extension of indication to include the preventive treatment of paediatric patients 1 year of age and older at high risk for recurrence of Clostridioides difficile infection (CDI).
    Zinplava is already authorised for the treatment of adult patients in the same indication.

Newly published EPARs

The EPAR – the European Public Assessment Report – is the main document where the EMA publishes the detailed information from the medicines assessed by the CHMP.

  • Ebglyss (lebrikizumab) is indicated for the treatment of moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older with a body weight of at least 40 kg who are candidates for systemic therapy.

CHMP Meeting Highlights November 2023

New Medicines Recommended for Authorisation

  • Rystiggo (rozanolixizumab) received a positive opinion as an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.
    gMG is a rare autoimmune disorder that causes muscle weakness. Around 90% of patients have detectable levels of autoantibodies in serum and the most common target AChR at the neuromuscular junction (NMJ), leading to failure of neuromuscular transmission. Rystiggo is a monoclonal antibody which targets the neonatal Fc receptor (FcRn). Thus, the binding of IgG antibodies to FcRn is suppressed and the intracellular degradation of the pathogenic autoantibodies is stimulated.

Recommendations on Extensions of Therapeutic Indication

  • Evkeeza (evinacumab): extension of indication, as an adjunct to diet and other low-density lipoprotein-cholesterol (LDL-C) lowering therapies, for the treatment paediatric patients aged 5 years and older with homozygous familial hypercholesterolaemia (HoFH).
    Evkeeza is already authorised for the treatment of adults and adolescents from 12 years of age.
  • Fluad tetra (influenza vaccine (surface antigen, inactivated, adjuvanted)): extension of indication to include prophylaxis of influenza in adults 50 years of age and older.
    Fluad tetra is already authorised for adults from 65 years of age.
  • Keytruda (pemprolizumab): extension of indication to include Keytruda, in combination with gemcitabine-based chemotherapy, for the first-line treatment of locally advanced unresectable or metastatic biliary tract carcinoma in adults.
    Keytruda is already authorised for the treatment of various types of solid cancer. In September and October 2023, Keytruda received positive opinions for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum-based chemotherapy, as well as for the first-line treatment, in combination with fluoropyrimidine and platinum-containing chemotherapy, of locally advanced unresectable or metastatic HER2-negative gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥ 1. Both EC decisions are pending.

CHMP Meeting Highlights October 2023

New Medicines Recommended for Authorisation

  • Elrexfio (elranatamab) received a positive opinion for a conditional marketing authorisation (CMA) for the treatment, as monotherapy, of adult patients with relapsed and refractory multiple myeloma (MM), who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.
    MM is a type of blood cancer characterised by the malignant proliferation of plasma cells that consistently express the B-cell maturation antigen (BCMA). BCMA is not expressed in normal non-haematopoietic cells. Elrexfio is a bispecific antibody that targets CD3, present on the surface of T-cells, and BCMA. Elrexfio binds CD3, thereby eliciting recruitment of effector T-cells. Upon concurrent binding with BCMA, T-cell activation occurs, resulting in T-cell-mediated B-cell lysis.

Recommendations on Extensions of Therapeutic Indication

  • Imfinzi (durvalumab): extension of indication to include, as monotherapy, the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC).
    Imfinzi was already authorised, as a combination therapy with chemotherapeutic agents and/or tremelimumab, for the treatment of HCC, small cell lung cancer, biliary tract cancer, and non-small cell lung cancer.
  • Jemperli (dostarlimab): extension of indication to include, in combination with carboplatin and paclitaxel, the treatment of adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer (EC) and who are candidates for systemic therapy.
    Jemperli was already authorised for the second-line treatment of the same subtype of endometrial cancer.
  • Keytruda (pembrolizumab): extension of indication to include, in combination with fluoropyrimidine and platinum-containing chemotherapy, the first-line treatment of locally advanced unresectable or metastatic HER2-negative gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥ 1.
    Keytruda was already authorised for the treatment of various types of cancer, including HER2-positive gastric or gastro-oesophageal junction (GEJ) adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥ 1. Last month, Keytruda received a positive CHMP opinion for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum-based chemotherapy. European commission (EC) decision is pending.
  • Praluent (alirocumab): extension of indication to the treatment of paediatric patients 8 years of age and older with heterozygous familial hypercholesterolaemia (HeFH) as an adjunct to diet, in combination with a statin, or statin with other lipid lowering therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin or, alone or in combination with other lipid-lowering therapies in patients who are statin-intolerant, or for whom a statin is contraindicated.
    Praluent was already authorised for the treatment of adults with primary hypercholesterolaemia (heterozygous familial and non-familial), mixed dyslipidaemia, or with established atherosclerotic cardiovascular disease.
  • Veyvondi (vonicog alfa): extension of indication to include the prevention of haemorrhage or surgical bleeding in adults (age 18 years and older) with von Willebrand disease (VWD), when desmopressin (DDAVP) treatment alone is ineffective or contraindicated.
    Veyvondi was already authorised for the treatment of haemorrhage or surgical bleeding in the same patient population.

Newly Published EPARs

The EPAR – the European Public Assessment Report – is the main document where the EMA publishes the detailed information from the medicines assessed by the CHMP.

  • Talvey (talquetamab) is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.
  • Tepkinly (epcoritamab) is indicated as monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.
  • Tevimbra (tislelizumab) is indicated as monotherapy for the treatment of adult patients with unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma after prior platinum-based chemotherapy.

Recently Started Marketing Authorisation Procedure

Every month, new medicinal products are submitted to the EMA for marketing authorisation, with the aim of providing patients with new treatment options for various diseases. The CHMP carries out a scientific assessment of the applications and makes a recommendation.

  • Crovalimab – Treatment of paroxysmal nocturnal haemoglobinuria.
  • Donanemab – To slow disease progression in adult patients with Alzheimer’s disease (AD).
  • In vitro diagnostic medical device – Detection of HER2 antigen.
  • In vitro diagnostic medical device – Detection of PD-L1 protein.
  • In vitro diagnostic medical device – Immunohistochemical assay utilising an anti-PDL1 monoclonal primary antibody.
  • Meningococcal group a, b, c, w and y vaccine – Indicated for active immunisation to prevent invasive disease caused by Neisseria meningitidis groups A, B, C, W, and Y.
  • Odronextamab – Orphan medicine – Treatment of blood cancers (follicular lymphoma (FL) or diffuse large B cell lymphoma (DLBCL) and large cell lymphoma).
  • Single-stranded 5' capped mRNA encoding the respiratory syncytial virus glycoprotein f stabilized in the prefusion conformation – Prevention of lower respiratory tract disease (LRTD) and acute respiratory disease (ARD) caused by respiratory syncytial virus (RSV).
  • Vilobelimab – Treatment of adult patients with SARS-CoV-2 induced septic acute respiratory distress syndrome (ARDS) receiving invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO).
  • Zapomeran – Active immunisation to prevent COVID-19.
  • Zolbetuximab – Orphan medicine – Treatment of locally advanced unresectable or metastatic HER2 negative gastric or gastro-oesophageal junction (GEJ) adenocarcinoma.

CHMP Meeting Highlights September 2023

New Medicines Recommended for Authorisation

  • Ebglyss (lebrikizumab) is indicated for the treatment of moderate-to-severe atopic dermatitis (AD) in adults and adolescents 12 years and older with a body weight of at least 40 kg who are candidates for systemic therapy. AD is a chronic and complex disease, characterised by dry and pruritic skin. The main contributors seem to be an altered permeability of the skin due to perturbations in the epidermal barrier and an inappropriate immune response, which results in skin inflammation and contributes to the epidermal barrier disruption. Interleukin 13 (IL-13) is believed to be key in the pathophysiology of AD. Ebglyss is a monoclonal antibody that binds and inhibits IL-13, thereby disrupting the cytokine signalling cascade involved in AD.

Recommendations on Extensions of Therapeutic Indication

  • Adcetris (brentuximab vedotin): extension of indication to the treatment of adult patients with previously untreated CD30+ Stage III Hodgkin lymphoma in combination with doxorubicin, vinblastine and dacarbazine. Adcetris was already authorised for different stages of Hodgkin lymphoma, and various lines of therapy; for systemic anaplastic large cell lymphoma and cutaneous T-cell lymphoma.
  • Enhertu (trastuzumab deruxtecan): extension of indication to include, as monotherapy, treatment of adult patients with advanced non-small cell lung cancer whose tumours have an activating HER2 (ERBB2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy. Enhertu was already authorised for breast cancer and gastric cancer.
  • Keytruda (pembrolizumab): extension of indication to include, as monotherapy, the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum-based chemotherapy. Keytruda was already authorised for the treatment of melanoma, non-small cell lung carcinoma, classical Hodgkin lymphoma, urothelial carcinoma, head and neck squamous cell carcinoma, renal cell carcinoma, colorectal cancer, oesophageal carcinoma, breast cancer, endometrial carcinoma, gastric or gastro-oesophageal junction (GEJ) adenocarcinoma, cervical cancer and several microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) cancers.
  • Nordimet (methtotrexate): update of indication to the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy severe and severe psoriatic arthritis in adult patients. Nordimet was previously authorised only in severe recalcitrant disabling psoriasis, not adequately responsive to other forms of therapy such as phototherapy, psoralens and ultraviolet A (PUVA), and retinoids, and severe psoriatic arthritis in adult patients. Nordimet was already authorised for the treatment of active rheumatoid arthritis, juvenile idiopathic arthritis and Crohn's disease.
  • Takhzyro (lanadelumab): extension of indication to the routine prevention of recurrent attacks of hereditary angioedema in patients aged 2 years and older. Takhzyro was previously authorised in patients 12 years of age and older.

Newly Published EPARs

The EPAR – the European Public Assessment Report – is the main document where the EMA publishes the detailed information from the medicines assessed by the CHMP.

  • Abrysvo (Respiratory syncytial virus vaccines) is indicated for:
    • Passive protection against lower respiratory tract disease caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age following maternal immunisation during pregnancy.
    • Active immunisation of individuals 60 years of age and older for the prevention of lower respiratory tract disease caused by RSV.

Recently Started Marketing Authorisation Procedure

Every month, new medicinal products are submitted to the EMA for marketing authorisation, with the aim of providing patients with new treatment options for various diseases. The CHMP carries out a scientific assessment of the applications and makes a recommendation.

  • Apadamtase alfa – Orphan medicine – Treatment of congenital thrombotic thrombocytopenic purpura due to ADAMTS13 deficiency.
  • Efanesoctocog alfa – Orphan medicine – Treatment and prophylaxis of bleeding in patients with haemophilia A.
  • Fidanacogene elaparvovec – Orphan medicine – ATMP – Indicated for the treatment of severe and moderately severe haemophilia B.

CHMP Meeting Highlights July 2023

New Medicines Recommended for Authorisation

  • Abrysvo (Respiratory syncytial virus vaccine) received a positive opinion for the:

    • Passive protection against lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in infants from birth through 6 months of age following maternal immunisation during pregnancy;
    • Active immunisation of individuals 60 years of age and older for the prevention of LRTD caused by RSV.

    RSV is a single-stranded RNA virus that causes the majority of cases of respiratory hospitalization in infants. In adults over 65 years of age, approximately 15% of acute respiratory infections due to RSV lead to hospitalisation. LRTD is characterised by bronchiolitis and pneumonia and it is potentially life-threatening. Abrysvo is a protein-based vaccine that consists of F glycoprotein ectodomains of RSV A and B, expressed in genetically engineered Chinese Hamster Ovary cell lines. There is a particularity of Abrysvo: at variance with other vaccines, the goal of the immunization of pregnant women is the protection not of the mother but of the child who will transplacentally receive the antibodies the mother’s immune system produces against RSV.

  • Talvey (talquetamab) received a positive opinion for a conditional marketing authorisation (CMA) for the treatment, as monotherapy, of adult patients with relapsed and refractory multiple myeloma (MM), who have received at least 3 prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.

    MM is a type of blood cancer characterized by the malignant proliferation of plasma cells. Talvey is a bispecific antibody that targets CD3, present on the surface of T-cells, and GPRC5D, a G protein–coupled receptor of unknown function but highly expressed in multiple myeloma cells. Talvey binds CD3, thereby eliciting recruitment of effector T-cells. Upon concurrent binding with GPRC5D, T-cell activation occurs, resulting in T-cell-mediated B-cell lysis. Talvey is the first therapy for the treatment of cancer targeting GPRC5D.

  • Tepkinly (epcoritamab) received a positive opinion for a conditional marketing authorisation (CMA) for the treatment, as monotherapy, of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.

    DLBCL is an aggressive cancer of the B-lymphocytes and it is the most common form of non-Hodgkin lymphoma. As many mature B-cell lymphomas, DLBCL express the surface antigen CD20. Tepkinly is a bispecific antibody that targets CD20 and CD3, a subunit of the T-cell receptor complex. Tepkinly binds CD3, thereby eliciting recruitment of effector T-cells. Upon concurrent binding with CD20, T-cell activation occurs, resulting in T-cell-mediated B-cell lysis.

  • Tevimbra (tislelizumab) received a positive opinion for the treatment, as monotherapy, of adult patients with unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma after prior platinum-based chemotherapy.

    Although oesophageal cancer is a rare disease in Europe, it is one of the most common cancers worldwide and it remains highly fatal. Tevimbra is a checkpoint inhibitor, targeting PD-1 (programmed cell death protein 1) on immune cells. Many cancer cells express a PD-1 ligand. Since activation of PD-1 down-regulates the immune system, blocking of the interaction between PD-1 and PD-L1 enhances the T cell responses against the cancer cells. Furthermore, Tevimbra was engineered to reduce Fc-mediated effector protein bindings, thereby reducing the antibody- and complement-dependent cytotoxicity.

Recommendations on Extensions of Therapeutic Indication

  • Ervebo (Ebola Zaire Vaccine [rVSV∆G-ZEBOV-GP, live]): extension of indication to the active immunisation of individuals 1 year of age or older to protect against Ebola Virus Disease caused by Zaire Ebola virus. Ervebo was already authorised in patients 18 years of age and older.
  • Foclivia (pandemic influenza vaccine [H5N1] [surface antigen, inactivated, adjuvanted]): extension of indication to include children from 6 months to less than 18 years of age for the prophylaxis of influenza in an officially declared pandemic situation.
  • Keytruda (pembrolizumab): extension of indication for the first-line treatment, in combination with trastuzumab, fluoropyrimidine and platinum-containing chemotherapy, of locally advanced unresectable or metastatic HER2-positive gastric or gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with a CPS ≥ 1. Keytruda was already authorised for the treatment of melanoma, non-small cell lung carcinoma, classical Hodgkin lymphoma, urothelial carcinoma, head and neck squamous cell carcinoma, renal cell carcinoma, colorectal cancer, oesophageal carcinoma, breast cancer, endometrial carcinoma, cervical cancer and several microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) cancers.
  • Opdivo (nivolumab): extension of indication to the adjuvant treatment, as monotherapy, of adults and adolescents 12 years of age and older with Stage IIB or IIC melanoma, or melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection. This adds the treatment of stage IIB and IIC melanoma to the existing indication. Opdivo was furthermore already authorised for the treatment of melanoma, non-small cell lung cancer, malignant pleural mesothelioma, renal cell carcinoma, classical Hodgkin lymphoma, squamous cell cancer of the head and neck, urothelial carcinoma, colorectal cancer, oesophageal squamous cell carcinoma, and gastric, gastro-oesophageal junction and oesophageal adenocarcinoma.
  • Spikevax bivalent Original/Omicron BA.4-5 (elasomeran / imelasomeran and elasomeran / davesomeran and elasomeran / COVID-19 mRNA vaccine [nucleoside-modified]): extension of indication to the active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. Previously, Spikevax bivalent Original/Omicron BA.4-5 was authorised in individuals 6 years of age and older and only after receiving at least a primary vaccination course against COVID-19.

Newly Published EPARs

The EPAR – the European Public Assessment Report – is the main document where the EMA publishes the detailed information from the medicines assessed by the CHMP.

  • Briumvi (ublituximab) is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis with active disease defined by clinical or imaging features.
  • Columvi (glofitamab) as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, after two or more lines of systemic therapy.

CHMP Meeting Highlights June 2023

Recommendations on Extensions of Therapeutic Indication

  • Comirnaty Original/Omicron BA.4-5 (COVID-19 mRNA Vaccine [nucleoside modified]): extension of indication to include the active immunisation to prevent COVID-19 in individuals 6 months of age and older who have not previously received at least a primary vaccination course against COVID-19. Previously, Comirnaty Original/Omicron BA.4-5 was only authorised in patients who had previously received at least a primary vaccination course against COVID-19. The dose is different in the different age groups.
  • Imjudo (tremelimumab): extension of indication to the first-line treatment of adults with metastatic non-small cell lung cancer with no sensitising EGFR mutations or ALK positive mutations, in combination with durvalumab and platinum-based chemotherapy. Imjudo was already authorised for the treatment of hepatocellular carcinoma.
  • Refixia (nonacog beta pegol): extension of indication to include the treatment and prophylaxis of bleeding in patients below 12 years of age with haemophilia B (congenital factor IX deficiency). Refixia was already authorised in patients 12 years of age and older.
  • Soliris (eculizumab): extension of indication to include the treatment of refractory generalized myasthenia gravis in patients aged 6 years and above who are anti-acetylcholine receptor (AChR) antibody-positive. Soliris was already authorised in this indication in adults. Furthermore, Soliris was already authorised for the treatment of paroxysmal nocturnal haemoglobinuria, atypical haemolytic uremic syndrome and neuromyelitis optica spectrum disorder.
  • Trodelvy (sacituzumab govitecan): extension of indication to the treatment as monotherapy of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received endocrine-based therapy, and at least two additional systemic therapies in the advanced setting. Trodelvy was already authorised for the treatment of triple-negative breast cancer.

Newly published EPARs

The EPAR – the European Public Assessment Report – is the main document where the EMA publishes the detailed information from the medicines assessed by the CHMP.

  • Arexvy (Recombinant respiratory syncytial virus pre-fusion F protein, adjuvanted with AS01E) is indicated for active immunisation for the prevention of lower respiratory tract disease caused by respiratory syncytial virus in adults 60 years of age and older.
  • Bimervax (COVID-19 Vaccine [recombinant, adjuvanted]) is indicated as a booster for active immunisation to prevent COVID-19 in individuals 16 years of age and older who have previously received a mRNA COVID-19 vaccine.
  • Omvoh (mirikizumab) is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic treatment.

Recently Started Marketing Authorisation Procedure

Every month, new medicinal products are submitted to the EMA for marketing authorisation, with the aim of providing patients with new treatment options for various diseases. The CHMP carries out a scientific assessment of the applications and makes a recommendation.

  • COVID-19 vaccine – Immunisation to prevent COVID-19 caused by SARS-CoV-2.
  • In vitro diagnostic medical device – Indicated as an aid in the selection of adult hemophilia A patients for whom valoctocogene roxaparvovec treatment is being considered.
  • Retifanlimab – Orphan medicine – Treatment of Merkel cell carcinoma.
  • Serplulimab – Orphan medicine – First-line treatment of adult patients with extensive-stage small cell lung cancer.

CHMP Meeting Highlights May 2023

Recommendations on Extensions of Therapeutic Indication

  • Opdivo (nivolumab): extension of indication to the neoadjuvant treatment of resectable non-small cell lung cancer at high risk of recurrence in adult patients whose tumours have PD-L1 expression ≥ 1%, in combination with platinum-based chemotherapy. Opdivo was already authorised for the treatment of melanoma, non-small cell lung cancer, malignant pleural mesothelioma, renal cell carcinoma, classical Hodgkin lymphoma, squamous cell cancer of the head and neck, urothelial carcinoma, colorectal cancer, oesophageal squamous cell carcinoma, and gastric, gastro-oesophageal junction and oesophageal adenocarcinoma.

Recently Started Marketing Authorisation Procedure

Every month, new medicinal products are submitted to the EMA for marketing authorisation, with the aim of providing patients with new treatment options for various diseases. The CHMP carries out a scientific assessment of the applications and makes a recommendation.

  • In vitro diagnostic medical device – To determine Human Epidermal Growth Factor Receptor 2 (HER2) oncoprotein status.
  • rdESAT-6 + rCFP-10 – Diagnosis of infection with Mycobacterium tuberculosis.
  • Sugemalimab – Treatment of adults with metastatic non-small cell lung cancer.

CHMP Meeting Highlights April 2023

New Medicines Recommended for Authorisation

  • Arexvy (Respiratory Syncytial Virus (RSV) vaccine [recombinant, adjuvanted]) is indicated for active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus in adults 60 years of age and older.
    RSV is a single-stranded RNA virus that infects people of all ages but does not confer long-term immunity. In vulnerable individuals, such as older adults, re-infections could lead to more severe manifestations of the disease, such as LRTD. Arexvy includes an engineered version of the well conserved RSV F surface glycoprotein, which is required for the entry of the virus into the cell.
    Arexvy is the first vaccine authorised to protect adults from RSV.
  • Columvi (glofitamab) received a positive opinion for a Conditional Marketing Authorisation (CMA) for the treatment, as monotherapy, of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy.

    DLBCL is an aggressive cancer of the B-lymphocytes and it is the most common form of non-Hodgkin lymphoma. As many mature B-cell lymphomas, DLBCL express the surface antigen CD20. Columvi is a bispecific antibody that targets CD20 and CD3, a subunit of the T-cell receptor complex. Columvi binds CD3, thereby eliciting recruitment of effector T-cells. Upon concurrent binding with CD20, T-cell activation occurs, resulting in T-cell-mediated B-cell lysis.

Recommendations on Extensions of Therapeutic Indication

  • Bimzelx (bimekizumab) has received a positive opinion for the following extension of indications:
    • For the treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein and/or magnetic resonance imaging (MRI) who have responded inadequately or are intolerant to non-steroidal anti-inflammatory drugs;
    • For the treatment of adults with active ankylosing spondylitis who have responded inadequately or are intolerant to conventional therapy; and
    • For the treatment, alone or in combination with methotrexate, of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs.
      Bimzelx was already authorised for the treatment of plaque psoariasis.
  • Cosentyx (secukinumab): extension of indication to the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adults with an inadequate response to conventional systemic hidradenitis suppurativa therapy. Cosentyx was already authorised for the treatment of plaque psoriasis, psoriatic arthritis, axial spondyloarthritis and juvenile idiopathic arthritis.
  • Opdivo (nivolumab): extension of indication to adolescents 12 years of age and older:
    • For the treatment of advanced (unresectable or metastatic) melanoma, as monotherapy or in combination with ipilimumab;
    • For the adjuvant treatment of melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resection, as monotherapy.
      Opdivo was already authorised in these indications in adults. Furthermore, Opdivo was already authorised for the treatment of non-small cell lung cancer, malignant pleural mesothelioma, renal cell carcinoma, classical Hodgkin lymphoma, squamous cell cancer of the head and neck, urothelial carcinoma, mismatch repair deficient or microsatellite instability-high colorectal cancer, oesophageal squamous cell carcinoma, oesophageal or gastro-oesophageal junction (GEJ) cancer and gastric, GEJ or oesophageal adenocarcinoma.
  • Ronapreve (casirivimab / imdevimab): extension of indication to the treatment of COVID-19 in adults and adolescents aged 12 years and older weighing at least 40 kg and receiving supplemental oxygen, who have a negative SARS-CoV-2 antibody test result. Ronapreve was already authorised for the prevention of COVID-19 and for treatment of COVID-19 in patients who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.
  • Spikevax bivalent Original/Omicron BA.4-5 (elasomeran): extension of indication to the active immunisation to prevent COVID-19 in individuals 6 years of age and older who have previously received at least a primary vaccination course against COVID-19. Spikevax bivalent Original/Omicron BA.4-5 was already authorised in patients aged 12 years of age and older.
  • Yervoy (ipilimumab): extension of indication to the treatment of adolescents 12 years of age and older with advanced (unresectable or metastatic) melanoma, in combination with nivolumab. Yervoy was already authorised in this indication as monotherapy. Furthermore, Yervoy was also already authorised for the treatment of renal cell carcinoma, non-small cell lung cancer, malignant pleural mesothelioma, mismatch repair deficient or microsatellite instability-high colorectal cancer and oesophageal squamous cell carcinoma.

Recently Started Marketing Authorisation Procedure

Every month, new medicinal products are submitted to the EMA for marketing authorisation, with the aim of providing patients with new treatment options for various diseases. The CHMP carries out a scientific assessment of the applications and makes a recommendation.

  • Bevacizumab – Treatment of neovascular (wet) age-related macular degeneration.
  • Concizumab – Routine prophylaxis to prevent or reduce the frequency of bleeding in patients with:
    • haemophilia A (congenital factor VIII deficiency) with FVIII inhibitors ≥ 12 years of age;
    • haemophilia B (congenital factor IX deficiency) with FIX inhibitors of any age.
  • Elranatamab – Orphan medicine - Treatment of adult patients with relapsed or refractory multiple myeloma.
  • Exagamglogene autotemcel – Advanced Therapy Medicinal Product (ATMP) – Treatment of transfusion-dependent β-thalassemia and sickle cell disease.
  • Influenza virus a/turkey/turkey/1/2005 (h5n1) nibrg-23 strain
  • Lecanemab – A disease modifying treatment in adult patients with Mild Cognitive Impairment due to Alzheimer’s disease and Mild Alzheimer’s disease (Early Alzheimer’s disease)
  • Pandemic influenza vaccine (surface antigen, inactivated, adjuvanted) – Active immunisation for the prevention of disease caused by the influenza A virus H5N1 subtype contained in the vaccine.
  • Respiratory syncytial virus vaccine – Prevention of respiratory tract disease.
  • Talquetamab – Orphan medicine - Monotherapy treatment of adult patients with relapsed and refractory multiple myeloma.

CHMP Meeting Highlights March 2023

New Medicines Recommended for Authorisation

  • Bimervax (COVID-19 Vaccine [recombinant, adjuvanted]) is indicated as a booster for active immunisation to prevent COVID-19 in individuals 16 years of age and older who have previously received an mRNA COVID-19 vaccine.
    COVID-19 is a contagious disease caused by the Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Although this virus can infect a wide variety of cells, it is most known for causing respiratory tract symptoms, which vary from mild to severe. The virus enters the cells mainly by binding to the angiotensin converting enzyme 2 (ACE2). Bimervax is a vaccine harbouring a recombinant modified Spike protein antigen. The Spike protein is the major viral surface protein and it mediates viral entry by binding to ACE2 on the host cell. Bimervax is the eighth vaccine recommended in the European Union for protecting against COVID-19. However, it has only received a positive opinion as a booster and not for primary vaccination.
  • Briumvi (ublituximab) is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis with active disease defined by clinical or imaging features.
    Multiple sclerosis is a chronic neurodegenerative autoimmune disease of the central nervous system, which leads to irreversible decrease in physical and cognitive function. Briumvi is an immunosuppressant monoclonal antibody, which binds to the CD20 surface antigen of B-cells, leading to antibody-dependent cell death.
  • Omvoh (mirikizumab) is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a biologic treatment.
    UC is a chronic inflammatory disease that affects the colon. Although the aetiology is not fully understood, many factors seem to be involved in the pathogenesis of the disease, including altered immune responses, environmental and genetics factors. Omvoh is a monoclonal antibody that binds to interleukin 23 (IL-23), a pro-inflammatory cytokine involved in promoting inflammation in UC, and inhibits its binding to the IL23 receptor, thereby disrupting the cytokine signalling cascade.

Recommendations on Extensions of Therapeutic Indication

  • Breyanzi (lisocabtagene maraleucel): extension of indication to the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL), high grade B cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy. Breyanzi was already authorised for the treatment of relapsed or refractory DLBCL, PMBCL and FL3B, after two or more lines of systemic therapy.
  • Ultomiris (ravulizumab): extension of indication to the treatment of adult patients with neuromyelitis optica spectrum disorder who are anti-aquaporin 4 (AQP4) antibody-positive. Ultomiris was already authorised for the treatment of paroxysmal nocturnal haemoglobinuria, atypical haemolytic uremic syndrome and generalized myasthenia gravis.

Newly Published EPARs

The EPAR – the European Public Assessment Report – is the main document where the EMA publishes the detailed information from the medicines assessed by the CHMP.

  • Imjudo (tremelimumab) in combination with durvalumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma.
  • Tremelimumab AstraZeneca (tremelimumab) in combination with durvalumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small cell lung cancer with no sensitising EGFR mutations or ALK positive mutations.

Recently Started Marketing Authorisation Procedure

Every month, new medicinal products are submitted to the EMA for marketing authorisation, with the aim of providing patients with new treatment options for various diseases. The CHMP  carries out a scientific assessment of the applications and makes a recommendation.

  • In vitro diagnostic medical device – To detect internal tandem duplication and tyrosine kinase domain mutations D835 and I836 in the FLT3
  • Rozanolixizumab – Orphan - Treatment of generalised myasthenia gravis.
  • Toripalimab – Combination treatment for metastatic or recurrent locally advanced nasopharyngeal carcinoma and for metastatic or recurrent oesophageal squamous cell carcinoma.

CHMP Meeting Highlights February 2023

Recommendations on Extensions of Therapeutic Indication

  • Libtayo (cemiplimab): extension of indication to include, in combination with platinum‐based chemotherapy, the first-line treatment of adult patients with non-small cell lung cancer (NSCLC) expressing PD-L1 (in ≥ 1% of tumour cells), with no EGFR, ALK or ROS1 aberrations, who have locally advanced NSCLC who are not candidates for definitive chemoradiation, or metastatic NSCLC.
    Libtayo as monotherapy was already authorised for the first-line treatment of adult patients with NSCLC expressing PD-L1 (in ≥ 50% tumour cells), with no EGFR, ALK or ROS1 aberrations, who have locally advanced NSCLC and who are not candidates for definitive chemoradiation, or metastatic NSCLC.
    Furthermore, Libtayo was already authorised for the treatment of cutaneous squamous cell carcinoma, basal cell carcinoma and cervical cancer.
  • TachoSil (human fibrinogen/human thrombin): extension of indication to the supportive treatment of children from 1 month of age in surgery for improvement of haemostasis, to promote tissue sealing and for suture support in vascular surgery where standard techniques are insufficient. TachoSil was already authorised in adults in this indication and for supportive sealing of the dura mater to prevent postoperative cerebrospinal leakage following neurological surgery.

Newly Published EPARs

The EPAR – the European Public Assessment Report – is the main document where the EMA publishes the detailed information from the medicines assessed by the CHMP.

  • Hemgenix (etranacogene dezaparvovec) is indicated for the treatment of severe and moderately severe Haemophilia B (congenital Factor IX deficiency) in adult patients without a history of Factor IX inhibitors.
  • Spevigo (spesolimab) is indicated for the treatment of flares in adult patients with generalised pustular psoriasis as monotherapy.

Recently Started Marketing Authorisation Procedure

Every month, new medicinal products are submitted to the EMA for marketing authorisation, with the aim of providing patients with new treatment options for various diseases. The CHMP  carries out a scientific assessment of the applications and makes a recommendation.

  • Epcoritamab – Orphan - Treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma.
  • Lebrikizumab – Treatment of moderate-to-severe atopic dermatitis in adults and adolescents.

Other Topics of Interest

Update on the following authorised medicine for the treatment or prevention of COVID-19:

The CHMP has recommended authorising the use of COVID-19 Vaccine Valneva (inactivated, adjuvanted) as a booster dose for adults 18 to 50 years of age.

CHMP Meeting Highlights January 2023

Recommendations on Extensions of Therapeutic Indication

  • Dupixent (dupilumab): extension of indication to the treatment of severe atopic dermatitis (AD) in children 6 months to 11 years old who are candidates for systemic therapy. Dupixent was already authorised in children 6 to 11 years old in this setting and in adults and adolescents older than 12 year for the treatment of moderate-to-severe AD. Furthermore, Dupixent was already authorised for the treatment of asthma, chronic rhinosinusitis with nasal polyposis and prurigo nodularis.

Newly Published EPARs

The EPAR – the European Public Assessment Report – is the main document where the EMA publishes the detailed information from the medicines assessed by the CHMP.

  • Ebvallo (tabelecleucel) is indicated as monotherapy for treatment of adult and paediatric patients 2 years of age and older with relapsed or refractory Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy. For solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate. Ebvallo is an advanced therapy medicinal product (ATMP) composed of allogeneic T-cells, selected for their specific immunological function (lysis of EBV+ targets) and sufficient human leukocyte antigen (HLA) similarity between donor and recipient. Although limited to a niche indication, the use of allogenic T-cells is a new, previously unauthorized mode of action for the immunotherapy of cancer.
  • Zynlonta (loncastuximab tesirine), as monotherapy, is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma and high-grade B-cell lymphoma, after two or more lines of systemic therapy.

2022

CHMP Meeting Highlights December 2022

New Medicines Recommended for Authorisation

  • Hemgenix (etranacogene dezaparvovec) received a positive opinion for a conditional marketing authorisation (CMA) for the treatment of severe and moderately severe Haemophilia B (congenital factor IX deficiency) in adult patients without a history of factor IX (FIX) inhibitors.
    Congenital haemophilia is an X-linked recessive disease caused by mutations in the genes coding for the coagulation factor VIII (haemophilia A) or IX (haemophilia B). It is characterised by the inability to form blood clots, which results in a higher risk of bruising, internal bleeding and bleeding inside the joints. The disease can be classified as mild, moderate or severe, depending on the endogenous plasma activity levels of clotting factors. Patients who are treated with anti-haemophilic factors to replace the deficient coagulation factor can develop anti-factor VIII or IX alloantibodies (inhibitors), which neutralise the activity of the administered replacement factors.
    Hemgenix is an adeno-associated virus 5 (AAV5) vector that encodes FIX under the control of a liver-specific promoter. Hemgenix is designed for prolonged expression and is, therefore, delivered by a single intravenous dose. Hemgenix is an advanced therapy medicinal product (ATMP).
  • Imjudo (tremelimumab) received a positive opinion for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC), in combination with durvalumab (see Imfinzi below).
    HCC is the most common primary liver cancer (around 90% of cases). The incidence increases progressively with age and it is 2 to 3 times higher in men than in women. Some risk factors include chronic hepatitis B or C virus infection, high alcohol intake. Tremelimumab is a monoclonal antibody that targets the cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). CTLA-4 is an immune checkpoint that acts by downregulating immune responses. By targeting and blocking CTLA-4, the checkpoint inhibitor tremelimumab activates the immune system, allowing T-lymphocytes to destroy cancer cells.
  • Tremelimumab AstraZeneca (tremelimumab) received a positive opinion for the first-line treatment of adults with metastatic non-small cell lung cancer (NSCLC) with no sensitising epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) positive mutations, in combination with durvalumab and platinum-based chemotherapy (see Imfinzi below).
    NSCLC is a serious and often fatal disease that accounts for over 85% of all lung cancers. In NSCLC patients whose tumours lack driver mutations such as in the EGFR or ALK genes and can, therefore, not benefit from the respective targeted therapies, there is a high need for new and more efficacious therapies. Tremelimumab is a monoclonal antibody that targets CTLA-4 (see Imjudo above).

Recommendations on Extensions of Therapeutic Indication

  • Dupixent (dupilumab): extension of indication to the treatment of eosinophilic esophagitis in adults and adolescents 12 years and older, weighing at least 40 kg, who are inadequately controlled by, are intolerant to, or who are not candidates for conventional medicinal therapy. Dupixent was already authorised for the treatment of prurigo nodularis, atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis.
  • Enhertu (trastuzumab deruxtecan): extension of indication to include the treatment as monotherapy of adult patients with unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-low breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within 6 months of completing adjuvant chemotherapy. Enhertu was already authorised for gastric cancer and HER2-positive breast cancer (only in patients who have received one or more prior anti-HER2-based regimens).
  • Hemlibra (emicizumab): extension of indication to the routine prophylaxis of bleeding episodes in patients with haemophilia A without factor VIII inhibitors who have moderate disease (factor VIII (FVIII) ≥ 1% and ≤ 5%) with severe bleeding phenotype. Hemlibra was already authorised in patients with factor VIII inhibitors and without factor VIII inhibitors who have severe disease (FVIII < 1%).
  • Imfinzi (durvalumab) has received this month a positive opinion for two new indications:

    • the first-line treatment of adults with metastatic non-small cell lung cancer with no sensitising epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) positive mutations, in combination with tremelimumab and platinum-based chemotherapy (see Tremelimumab AstraZeneca above).
    • the first line treatment of adults with advanced or unresectable hepatocellular carcinoma, in combination with tremelimumab (see Imjudo above).

    Imfinzi was already authorised for the treatment of small cell lung cancer, biliary tract cancer and non-small cell lung cancer with programmed cell death ligand-1 (PD-L1) expression ≥ 1%.

Newly published EPARs

The EPAR – the European Public Assessment Report – is the main document where the EMA publishes the detailed information from the medicines assessed by the CHMP.

  • Beyfortus (nirsevimab) is indicated for the prevention of Respiratory Syncytial Virus (RSV) lower respiratory tract disease in neonates and infants during their first RSV season.
  • Enjaymo (sutimlimab) is indicated for the treatment of haemolytic anaemia in adult patients with cold agglutinin disease.
  • Qdenga (dengue tetravalent vaccine [live, attenuated]) is indicated for the prevention of dengue disease in individuals from 4 years of age.
  • VidPrevtyn Beta (COVID-19 Vaccine [recombinant, adjuvanted]) is indicated as a booster for active immunisation to prevent COVID-19 in adults who have previously received an mRNA or adenoviral vector COVID-19 vaccine.

Recently Started Marketing Authorisation Procedure

Every month, new medicinal products are submitted to the EMA for marketing authorisation, with the aim of providing patients with new treatment options for various diseases. The CHMP carries out a scientific assessment of the applications and makes a recommendation.

  • Catumaxomab – Indicated for the treatment of malignant ascites.
  • GBP510 – Prevention of COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older.

Other Topics of Interest

Update on the following authorised medicine for the treatment or prevention of COVID-19:

The CHMP has recommended extending the indication of COVID-19 vaccine Spikevax (original) and Spikevax bivalent Original/Omicron BA.1 as a booster dose in children aged 6 to 11 years.

The COVID-19 vaccine Jcovden has been recommended for a switch from CMA to standard authorization following the submission of data that fulfils the outstanding specific obligations.

CHMP Meeting Highlights November 2022

New Medicines Recommended for Authorisation

  • VidPrevtyn Beta (COVID-19 vaccine [recombinant, adjuvanted]) is indicated as a booster for active immunisation to prevent COVID-19 in adults who have previously received an mRNA or adenoviral vector COVID-19 vaccine.

    COVID-19 or Coronavirus disease 2019, is a contagious disease caused by the Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Although this virus can infect a wide variety of cells, it is most known for causing respiratory tract symptoms, which vary from mild to severe. The virus enters the cells mainly by binding to the angiotensin converting enzyme 2 (ACE2). VidPrevtyn Beta is a vaccine harbouring a recombinant modified Spike protein antigen. The Spike protein is the major viral surface protein and it mediates viral entry by binding to ACE2 on the host cell. VidPrevtyn Beta is the seventh vaccine recommended in the European Union for protecting against COVID-19. However, it has only received a positive opinion as a booster and not for primary vaccination.

Recommendations on Extensions of Therapeutic Indication

  • Ceprotin (human protein C): The indication has been updated as follows: for prophylaxis and treatment of purpura fulminans, coumarin-induced skin necrosis and venous thrombotic events in patients with severe congenital protein C deficiency. Importantly, venous thrombotic events has been newly added to the extended indication.
  • Dupixent (dupilumab): Extension of indication to include the treatment of adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy. Dupixent was already authorised for the treatment of atopic dermatitis, asthma and chronic rhinosinusitis with nasal polyposis.
  • Enhertu (trastuzumab deruxtecan): Extension of indication to include the treatment, as monotherapy, of adult patients with advanced Human Epidermal Growth Factor Receptor 2 (HER2)-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen. Enhertu was already authorised for the treatment of breast cancer.
  • Imfinzi (durvalumab): Extension of indication to include the first-line treatment of adults with unresectable or metastatic biliary tract cancer, in combination with gemcitabine and cisplatin. Imfinzi was previously authorised for the treatment of non-small cell lung cancer and extensive-stage small cell lung cancer.

Recently Started Marketing Authorisation Procedure

Every month, new medicinal products are submitted to the EMA for marketing authorisation, with the aim of providing patients with new treatment options for various diseases. The CHMP carries out a scientific assessment of the applications and makes a recommendation.

  • In vitro medical device – Human albumin solution / gentamicin sulfate: Human assisted reproductive techniques including in vitro fertilisation procedures
  • In vitro diagnostic medical device: In vitro qualitative immunohistochemical detection of programmed death-ligand 1 (PD-L1)
  • Trastuzumab duocarmazine: Treatment of HER2 (Human Epidermal Growth Factor Receptor 2)-positive metastatic breast cancer

Other Topics of Interest

Update on the following authorised medicine for the treatment or prevention of COVID-19:

  • The CHMP has recommended extending the indication of COVID-19 vaccine Comirnaty targeting the original strain and Omicron subvariants BA.4 and BA.5 to children between 5 to 11 years of age. The extension of indication is as follows:
    Comirnaty Original/Omicron BA.4-5 (5/5 micrograms)/dose dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in children 5 to 11 years of age who have previously received at least a primary vaccination course against COVID-19.

CHMP Meeting Highlights October 2022

New Medicines Recommended for Authorisation

  • Ebvallo (tabelecleucel) received a positive opinion for an authorisation under exceptional circumstances for the treatment, as monotherapy, of adult and paediatric patients 2 years of age and older with relapsed or refractory Epstein-Barr virus positive post-transplant lymphoproliferative disease (EBV+ PTLD) who have received at least one prior therapy. For solid organ transplant patients, prior therapy includes chemotherapy unless chemotherapy is inappropriate.
    EBV+ PTLD is a rare hematologic malignancy that develops in patients under immunosuppression after organ or hematopoietic cell transplant. Ebvallo is an advanced therapy medicinal product (ATMP) composed of allogeneic anti-EBV cytotoxic T cells.
  • Qdenga [dengue tetravalent vaccine (live, attenuated)] is indicated for the prevention of dengue disease in individuals from 4 years of age. Dengue fever is a mosquito-borne disease caused by the dengue virus, a single-stranded RNA virus of the flaviviridae family. Dengue fever is one of the most common vector-borne diseases globally. Dengue fever usually leads to mild, flu-like symptoms. However, unlike in most other cases, second infections tend to be more severe, with potentially fatal bleeding and organ damage. Antibody-dependent enhancement is presumed to be the main cause of the more severe clinical course of a second infection.
    Qdenga is a live attenuated viral vaccine, which replicates locally and elicits an immune response against the 4 viral serotypes. Qdenga is indicated for both seropositive and seronegative persons. Accordingly, no determination of serostatus is necessary prior to vaccination, at variance with the previously authorised vaccine Dengvaxia ®, which is indicated for persons with test-confirmed previous dengue infection only.
  • Spevigo (spesolimab) received a positive opinion for a conditional marketing authorisation for the treatment of flares in adult patients with generalised pustular psoriasis (GPP) as monotherapy. GPP is a potentially fatal rare type of psoriasis, a chronic inflammatory skin disease, characterised by the eruption of pustules on the skin, as well as the presence of systemic symptoms such as fever. Although it is unclear what triggers the flares, mutations in the interleukin-36 receptor gene (IL-36R) have been shown to cause GPP. Spevigo is a monoclonal antibody that targets IL-36R and blocks the binding to its ligands, thereby exerting its immunosuppressive function.

Recommendations on Extensions of Therapeutic Indication

  • Libtayo (cemiplimab): extension of indication to include the treatment of adult patients with recurrent or metastatic cervical cancer and disease progression on or after platinum-based chemotherapy, as monotherapy. Libtayo was already authorised for the treatment of cutaneous squamous cell carcinoma, basal cell carcinoma and non-small cell lung cancer.

Newly Published EPARs

The EPAR – the European Public Assessment Report – is the main document where the EMA publishes the detailed information from the medicines assessed by the CHMP.

  • Tecvayli (teclistamab) is indicated as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.
  • Tezspire (tezepelumab) is indicated as an add-on maintenance treatment in adults and adolescents 12 years and older with severe asthma who are inadequately controlled despite high dose inhaled corticosteroids plus another medicinal product for maintenance treatment.
  • Vabysmo (faricimab) is indicated for the treatment of adult patients with neovascular (wet) age-related macular degeneration or with visual impairment due to diabetic macular oedema.

Other Topics of Interest

The COVID-19 vaccine Vaxzevria has been recommended for a switch from CMA to standard authorization following the submission of data that fulfils the outstanding specific obligations.

CHMP Meeting Highlights September 2022

New Medicines Recommended for Authorisation

  • Beyfortus (nirsevimab) is indicated for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in neonates and infants during their first RSV season. RSV is a single-stranded RNA virus that causes the majority of cases of respiratory hospitalization in infants. LRTD is characterised by bronchiolitis and pneumonia and it is potentially life-threatening, specially during the first 6 months of life. Beyfortus is a monoclonal antibody targeted against the viral F surface protein, which is required for the fusion between the virus particle and the host cell.
  • Enjaymo (sutimlimab) is indicated for the treatment of haemolytic anaemia in adult patients with cold agglutinin disease (CAD). CAD is a rare autoimmune disease characterised by the presence at high concentrations of autoantibodies (usually IgMs) that target red blood cells (RBCs). These autoantibodies, or cold agglutinins, bind to RBCs causing their agglutination and haemolysis, mainly through activation of the classical pathway of the complement system. This is exacerbated at cold temperatures. Enjaymo is a first-in-class monoclonal antibody that targets the complement component 1s (C1s), thereby blocking the classical complement pathway cascade.
  • Zynlonta (loncastuximab tesirine) received a positive opinion for a conditional marketing authorisation (CMA) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy. DLBCL is an aggressive cancer of the B-lymphocytes and it is the most common form of non-Hodgkin lymphoma. HGBL is another aggressive type of B-cell non-Hodgkin lymphoma. Zynlonta is an antibody-drug conjugate that binds CD19 on the cell surface, forming a complex that is subject to endocytosis. The cleavage of Zynlonta within the lysosomes releases the drug portion of the conjugate, the pyrrolobenzodiazepine dimer cytotoxin tesirine, which binds to and cross-links DNA, thereby stalling DNA replication and blocking cell division, ultimately leading to cell death. CD19 is a transmembrane glycoprotein normally expressed in cells of the B lineage and its expression is kept in B-cell malignancies, such as DLBCL and HGBL.

Recommendations on Extensions of Therapeutic Indication

  • Adtralza (tralokinumab): extension of indication to include the treatment of moderate-to-severe atopic dermatitis in adolescent patients 12 years and older who are candidates for systemic therapy. Adtralza was already authorised in adults.
  • Evusheld (tixagevimab / cilgavimab): extension of indication to include the treatment of adults and adolescents (aged 12 years and older weighing at least 40 kg) with COVID-19, who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19. Evusheld was already authorised for the pre-exposure prophylaxis of COVID-19.
  • Skyrizi (risankizumab): extension of indication to include the treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy. Skyrizi was already authorised for the treatment of plaque psoriasis and psoriatic arthritis in adults.
  • Vaxneuvance (pneumococcal polysaccharide conjugate vaccine [15-valent, adsorbed]): extension of indication to the active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants, children and adolescents from six weeks to less than 18 years of age. Vaxneuvance was already authorised for the active immunisation for the prevention of invasive disease and pneumonia caused by S. pneumoniae in adults.
  • Yescarta (axicabtagene ciloleucel): extension of indication to the treatment of adult patients with diffuse large B-cell lymphoma and high-grade B-cell lymphoma that relapses within 12 months from completion of, or is refractory to, first-line chemoimmunotherapy. Yescarta was already authorised for the treatment of relapsed or refractory diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma and follicular lymphoma.

Newly Published EPARs

The EPAR – the European Public Assessment Report – is the main document where the EMA publishes the detailed information from the medicines assessed by the CHMP.

  • Roctavian (valoctocogene roxaparvovec) is indicated for the treatment of severe haemophilia A (congenital factor VIII deficiency) in adult patients without a history of factor VIII inhibitors and without detectable antibodies to adeno-associated virus serotype 5 (AAV5).
  • Upstaza (eladocagene exuparvovec) is indicated for the treatment of patients aged 18 months and older with a clinical, molecular, and genetically confirmed diagnosis of aromatic L-amino acid decarboxylase deficiency with a severe phenotype.

Recently Started Marketing Authorisation Procedure

Every month, new medicinal products are submitted to the EMA for marketing authorisation, with the aim of providing patients with new treatment options for various diseases. The CHMP carries out a scientific assessment of the applications and makes a recommendation.

  • Glofitamab: Orphan – Treatment of diffuse large B-cell lymphoma.
  • Mirikizumab: Treatment of moderately to severely active ulcerative colitis.
  • SARS-CoV-2 virus - beta-propiolactone inactivated: Active immunization against coronavirus disease 2019.

Other Topics of Interest

Update on the following authorised medicines for the treatment or prevention of COVID-19:

  • The CHMP recommended extending the use of Nuvaxovid (COVID-19 Vaccine [recombinant, adjuvanted]) as a booster in adults who have previously received Nuvaxovid.
  • The CHMP has recommended the authorisation of two adapted mRNA vaccines, Comirnaty Original/Omicron BA.1 and Spikevax bivalent Original/Omicron BA.1, intended for the immunisation against COVID-19 in people aged 12 years and above who have received at least primary vaccination against COVID-19. These vaccines target the Omicron BA.1 subvariant in addition to the original strain. Please see the EMA news announcement on Comirnaty and Spikevax.
  • The CHMP recommended the authorisation of the adapted bivalent mRNA vaccine Comirnaty Original/Omicron BA.4-5 for use in people aged 12 years and above who have received at least a primary course of vaccination against COVID-19. This vaccine is an adapted version that targets the Omicron subvariants BA.4 and BA.5 in addition to the original strain of SARS-CoV-2.
  • Additionally, the CHMP recommended that authorisation of Comirnaty as a booster in children from five to 11 years of age.
  • Furthermore, Comirnaty and Spikevax have been recommended for a switch from Conditional Marketing Authorisation (CMA) to standard authorization. After receiving a conditional marketing authorisation, the CHMP has now recommended granting a full marketing authorisation to these vaccines, following the submission of data that fulfils the outstanding specific obligations.

CHMP Meeting Highlights July 2022

New Medicines Recommended for Authorisation

  • Opdualag (relatlimab / nivolumab) is indicated for the first line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older with tumour cell PD-L1 expression < 1%.
    Melanoma is a cancer that develops from melanocytes, which are pigment-producing cells. The most common subtype is cutaneous melanoma. Unless detected and surgically removed at an early stage, melanomas massively metastasise. Available pharmacological therapies have considerably improved the survival of patients with metastatic melanoma. However, there is still a considerable number of patients who either fail to respond to or relapse after treatment with available therapies.
    Opdualag is a fixed-dose combination of the monoclonal antibodies relatlimab and nivolumab.
    Relatlimab is a monoclonal antibody targeting the cell surface receptor LAG-3 (lymphocyte-activation gene 3). Upon binding, relatlimab blocks ligand binding thereby promoting anti-tumour immunity. Nivolumab is a checkpoint inhibitor targeting PD-1 (programmed cell death protein 1) on immune cells and has previously been approved for the therapy of various cancers under the tradename Opdivo®. Many cancer cells express a PD-1 ligand (PD-1L). Since activation of PD-1 downregulates the immune system, blocking of the interaction between PD-1 and PD-L1 enhances the T cell responses against cancer cells.
  • Tecvayli (teclistamab) received a positive opinion for a conditional marketing authorisation (CMA) for the treatment, as monotherapy, of adult patients with relapsed and refractory multiple myeloma (MM), who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the last therapy. MM is a type of blood cancer characterized by the malignant proliferation of plasma cells that consistently express the B-cell maturation antigen (BCMA). BCMA is not expressed in normal non-hematopoietic cells.
    Tecvayli is a bispecific antibody that targets CD3, present on the surface of T-cells, and BCMA. Tecvayli binds CD3, thereby eliciting recruitment of effector T-cells. Upon concurrent binding with BCMA, T-cell activation occurs, resulting in T-cell-mediated B-cell lysis.
  • Tezspire (Tezepelumab) is indicated as an add-on maintenance treatment in adults and adolescents 12 years and older with severe asthma who are inadequately controlled despite high dose inhaled corticosteroids plus another medicinal product for maintenance treatment. Asthma is a chronic inflammatory disease of the airways characterised by airflow obstruction and bronchospasms. Although the etiology of the disease is unknown, environmental, genetic and psychogenic factors seem to contribute. Tezspire is a monoclonal antibody targeting the thymic stromal lymphopoietin (TSLP), a cytokine involved in the maturation of T lymphocytes. By inhibiting the binding of TSLP to its receptor, Tezspire blocks TSLP-mediated inflammation.
  • Vabysmo (faricimab) is indicated for the treatment of adult patients with neovascular (wet) age-related macular degeneration (nAMD) and visual impairment due to diabetic macular oedema (DME).
    Vascular endothelial growth factor A (VEGF-A) is the main protein responsible for the induction of blood vessel growth and, therefore, it is thought contribute to the pathophysiology of retinal vascular diseases, such as nAMD and DME. Angiopoietin 2 (Ang-2) is a cytokine that, together with VEGF, promotes angiogenesis. Faricimab is a bispecific antibody that targets VEGF-A and Ang-2, thereby blocking the binding to their receptors.

Recommendations on Extensions of Therapeutic Indication

  • Imvanex (live modified vaccinia virus Ankara): extension of indication to include the active immunisation against monkeypox and disease caused by vaccinia virus in adults. Imvanex had previously been authorised for the active immunisation against smallpox. For more information please see the EMA news announcement on Imvanex.
  • Tecartus (brexucabtagene autoleucel): extension of indication to the treatment of adult patients 26 years of age and above with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia. Tecartus had previously been authorised for the treatment of mantle cell lymphoma. Tecartus is an advanced therapy medicinal product (ATMP).
  • Ultomiris (ravulizumab): extension of indication as an add-on to standard therapy for the treatment of adult patients with generalised myasthenia gravis who are anti-acetylcholine receptor antibody-positive. Ultomitis had previously been authorised for the treatment of paroxysmal nocturnal haemoglobinuria and atypical haemolytic uremic syndrome.

Newly Published EPARs

The EPAR – the European Public Assessment Report – is the main document where the EMA publishes the detailed information from the medicines assessed by the CHMP.

  • (Valneva (COVID-19 vaccine [inactivated, adjuvanted, adsorbed]): is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 to 50 years of age.

Recently Started Marketing Authorisation Procedure

Every month, new medicinal products are submitted to the EMA for marketing authorisation, with the aim of providing patients with new treatment options for various diseases. The CHMP carries out a scientific assessment of the applications and makes a recommendation.

  • SARS-CoV-2 prefusion spike delta tm protein, recombinant: Active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older.

Other Topics of Interest

Update on the following authorised medicines for the treatment or prevention of COVID-19:

The CHMP recommended extending the use Spikevax as a booster in adolescents from 12 to 17 years of age. Spikevax (elasomeran / COVID-19 mRNA vaccine [nucleoside-modified]) is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 years of age and older.

CHMP Meeting Highlights June 2022

New Medicines Recommended for Authorisation

  • Roctavian (valoctocogene roxaparvovec) received a positive opinion for a conditional marketing authorisation (CMA) for the treatment of severe haemophilia A (congenital factor VIII deficiency) in adult patients without a history of factor VIII inhibitors and without detectable antibodies to adeno associated virus serotype 5 (AAV5).
    Congenital haemophilia is an X-linked recessive disease caused by mutations in the genes coding for the coagulation factor VIII (haemophilia A) or IX (haemophilia B). It is characterised by the inability to form blood clots, which results in a higher risk of bruising, internal bleeding and bleeding inside the joints. The disease can be classified as mild, moderate or severe, depending on the endogenous plasma activity levels of clotting factors. Patients who are treated with anti-haemophilic factors to replace the deficient coagulation factor can develop anti-factor VIII or XI alloantibodies (inhibitors), which neutralise the activity of the administered replacement factors.
    Roctavian is a AAV5 vector that encodes FVIII under the control of a liver-specific promoter. Roctavian is designed for prolonged expression and is, therefore, delivered by a single intravenous dose.
  • Valneva (COVID-19 vaccine (inactivated, adjuvanted, adsorbed)) is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 to 50 years of age.
    COVID-19 or Coronavirus disease 2019, is a contagious disease caused by the Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Although this virus can infect a wide variety of cells, it is most known for causing respiratory tract symptoms, which vary from mild to severe.
    Valneva is an inactivated viral vaccine and it is the sixth vaccine recommended in the European Union (EU) for protecting against COVID-19. You can find more information in the EMA news announcement for Valneva.

Recommendations on Extensions of Therapeutic Indication

  • Crysvita (burosumab): extension of indication to the treatment of FGF23-related hypophosphataemia in tumour-induced osteomalacia associated with phosphaturic mesenchymal tumours that cannot be curatively resected or localised in children and adolescents aged 1 to 17 years and in adults. Crysvita was already authorised for the treatment of X-linked hypophosphataemia.
  • Enhertu (trastuzumab deruxtecan): extension of indication, as monotherapy, to the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received one or more prior anti HER2 based regimens. Enhertu was previously authorised for patients who had received two or more prior anti HER2 based regimens.
  • Nuvaxovid (COVID-19 Vaccine (recombinant, adjuvanted)): extension of indication to the active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older. Nuvaxovid was already authorised for patients 18 years of age and older.

Newly Published EPARs

The EPAR – the European Public Assessment Report – is the main document where the EMA publishes the detailed information from the medicines assessed by the CHMP.

  • Carvykti (ciltacabtagene autoleucel) is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody and have demonstrated disease progression on the last therapy.
  • Lunsumio (mosunetuzumab) as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma who have received at least two prior systemic therapies.

Recently Started Marketing Authorisation Procedure

Every month, new medicinal products are submitted to the EMA for marketing authorisation, with the aim of providing patients with new treatment options for various diseases. The CHMP carries out a scientific assessment of the applications and makes a recommendation.

  • Etranacogene dezaparvovec (Orphan): Advanced therapy medicinal product (ATMP) - Treatment of adults with Haemophilia B (congenital Factor IX deficiency) and with a preexisting neutralising anti-AAV5 antibody titre below 1:700 to reduce the frequency of bleeding episodes and the need for Factor IX replacement therapy.
  • Tislelizumab (Orphan): Treatment of adult patients with unresectable, recurrent, locally advanced or metastatic oesophageal squamous cell carcinoma after prior chemotherapy.
  • Tislelizumab: Treatment of locally advanced or metastatic non-squamous non-small cell lung cancer in adults, treatment of locally advanced or metastatic squamous non-small cell lung cancer in adults, locally advanced or metastatic non-small cell lung cancer after prior chemotherapy in adults.
  • Tremelimumab (Orphan): For use in combination with durvalumab for the treatment of adults with unresectable hepatocellular carcinoma.

CHMP Meeting Highlights May 2022

New Medicines Recommended for Authorisation

  • Upstaza (eladocagene exuparvovec) received a positive opinion for an authorisation under exceptional circumstances based on an assessment by EMA’s Committee for Advanced Therapies (CAT) for the treatment of patients aged 18 months and older with a clinical, molecular, and genetically confirmed diagnosis of aromatic L-amino acid decarboxylase deficiency (AADCD) with a severe phenotype. AADC deficiency is an ultra-rare autosomal recessive disease caused by mutations in the gene encoding the enzyme AADC, which is involved in the synthesis and regulation of several neurotransmitters, such as dopamine, epinephrine and norepinephrine. Although the clinical presentation of AADC deficiency is heterogeneous, common symptoms include muscular hypotonia, movement disorders and developmental delay.
    Upstaza is the first medicine to receive a positive opinion for the treatment of AADC deficiency. It consists of an adeno-associated virus 2 (AAV2) containing the human DDC gene, which encodes the enzyme AADC. Upstaza is intended for a single treatment and is infused directly into the brain (putamen), where the AADC enzyme is subsequently expressed. The vector does not integrate in the host genome and has shown long-term expression in vivo. Upstaza is considered an advanced therapy medicinal product (ATMP). For more information see the EMA news announcement on Upstaza.

Recommendations on Extensions of Therapeutic Indication

  • Cosentyx (secukinumab): extension of indication, alone or in combination with methotrexate (MTX), to the treatment of active enthesitis-related arthritis and juvenile psoriatic arthritis in patients 6 years and older whose disease has responded inadequately to, or who cannot tolerate, conventional therapy.
    Cosentyx was already authorised for the treatment of adult and paediatric plaque psoriasis, psoriatic arthritis, axial and non-radiographic axial spondyloarthritis.
  • Keytruda (pembrolizumab): extension of indication, as monotherapy, to the treatment of adolescents aged 12 years and older with advanced (unresectable or metastatic) melanoma. Furthermore, extension of indication for Keytruda as monotherapy to the treatment of adults and adolescents ages 12 years and older with Stage IIB and IIC melanoma, who have undergone complete resection.
    Keytruda was already authorised for the treatment of melanoma, non-small cell lung cancer, classical Hodgkin lymphoma, urothelial cancer, head and neck squamous cell carcinoma, renal cell carcinoma, colorectal cancer, oesophageal carcinoma, triple-negative breast cancer, endometrial carcinoma, cervical cancer, gastric cancer, small intestine cancer and biliary cancer.

Newly Published EPARs

The EPAR – the European Public Assessment Report – is the main document where the EMA publishes the detailed information from the medicines assessed by the CHMP.

  • Evusheld (tixagevimab / cilgavimab) is indicated for the pre-exposure prophylaxis of COVID-19 in adults and adolescents aged 12 years and older weighing at least 40 kg.
  • Padcev (enfortumab vedotin) as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a programmed death receptor-1 or programmed death-ligand 1 inhibitor.
  • Prehevbri (hepatitis B surface antigen) is indicated for active immunisation against infection caused by all known subtypes of the hepatitis B virus in adults.
  • Uplizna (inebilizumab) is indicated as monotherapy for the treatment of adult patients with neuromyelitis opticaspectrum disorders (NMOSD) who are anti-aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive.

Recently Started Marketing Authorisation Procedure

Every month, new medicinal products are submitted to the EMA for marketing authorisation, with the aim of providing patients with new treatment options for various diseases. The CHMP carries out a scientific assessment of the applications and makes a recommendation.

  • Nirsevimab immunises infants from birth entering their first Respiratory Syncytial Virus (RSV) season for the prevention of RSV lower respiratory tract disease.
  • Teclistamab (Orphan): treatment of relapsed or refractory multiple myeloma.

CHMP Meeting Highlights April 2022

New Medicines Recommended for Authorisation

  • Lunsumio (mosunetuzumab) received a positive opinion for a conditional marketing authorisation (CMA) as monotherapy for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior systemic therapies. FL is the second most common non-Hodgkin lymphoma. Despite available therapies, FL remains an incurable disease. As many mature B-cell lymphomas, FL express the surface antigen CD20. Lusumio is a first-in-class bispecific antibody that targets CD20 and CD3, a subunit of the T-cell receptor complex. Lunsumio binds CD3, thereby eliciting recruitment of effector T-cells. Upon concurrent binding with CD20, T-cell activation occurs, resulting in T-cell-mediated B-cell lysis.

Recommendations on Extensions of Therapeutic Indication

  • Keytruda (pembrolizumab): extension of indication for the treatment of adults with locally advanced, or early-stage triple-negative breast cancer at high risk of recurrence, as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, in combination with chemotherapy.
    Keytruda had previously been authorised for the treatment of melanoma, non-small cell lung cancer, classical Hodgkin lymphoma, urothelial cancer, head and neck squamous cell carcinoma, renal cell carcinoma, colorectal cancer, oesophageal carcinoma, triple-negative breast cancer, endometrial carcinoma, cervical cancer, gastric cancer, small intestine cancer and biliary cancer.
  • NovoSeven [eptacog alfa (activated)]: extension of indication to include the treatment of severe postpartum haemorrhage when uterotonics are insufficient to achieve haemostasis. NovoSeven had previously been authorised for the treatment of bleeding episodes and for the prevention of bleeding in those undergoing surgery or invasive procedures who suffer certain coagulopathies.
  • Tecentriq (atezolizumab): extension of indication for Tecentriq as monotherapy, to include the adjuvant treatment following complete resection and platinum-based chemotherapy for adult patients with NSCLC with a high risk of recurrence whose tumours have PD-L1 expression on ≥ 50% of tumour cells and who do not have EGFR mutant or ALK-positive NSCLC.
    Tecentriq had previously been authorised for the treatment of urothelial carcinoma, NSCLC, small cell lung cancer, triple-negative breast cancer and hepatocellular carcinoma.
  • Yescarta (axicabtagene ciloleucel): extension of indication to include the treatment of adult patients with relapsed or refractory follicular lymphoma after three or more lines of systemic therapy. Yescarta had previously been authorised for the treatment of diffuse large B-cell lymphoma and primary mediastinal large B-cell lymphoma.

Newly Published EPARs

The EPAR – the European Public Assessment Report – is the main document where the EMA publishes the detailed information from the medicines assessed by the CHMP.

  • Breyanzi (lisocabtagene maraleucel): indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma and follicular lymphoma grade 3B, after two or more lines of systemic therapy.

Recently Started Marketing Authorisation Procedure

Every month, new medicinal products are submitted to the EMA for marketing authorisation, with the aim of providing patients with new treatment options for various diseases. The CHMP carries out a scientific assessment of the applications and makes a recommendation.

  • Nirsevimab: Prevention of RSV lower respiratory tract infection.

CHMP Meeting Highlights March 2022

New Medicines Recommended for Authorisation

  • Evusheld (tixagevimab / cilgavimab) is intended for the pre-exposure prophylaxis of COVID-19 in adults and adolescents aged 12 years and older weighing at least 40 kg. COVID-19 or Coronavirus disease 2019, is a contagious disease caused by the Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Although this virus can infect a wide variety of cells, it is most known for causing respiratory tract symptoms, which vary from mild to severe. The virus enters the cells mainly by binding to the angiotensin converting enzyme 2 (ACE2). Although a number of vaccines are authorised for the active immunisation against SARS-CoV-2, a high unmet medical still exist for the prophylaxis against COVID-19 in those individuals contraindicated for vaccination, or those who are not expected to mount an adequate immune response after vaccination. Evusheld consists of two monoclonal antibodies, tixagevimab and cigavimab, which target two distinct epitopes of the receptor binding domain (RBD) of the SARS-CoV-2 Spike protein, thereby inhibiting interaction with the cellular ACE2 and blocking viral entry into the cell.
  • Carvykti (ciltacabtagene autoleucel) received a positive opinion for a conditional marketing authorisation (CMA) based on an assessment by EMA’s Committee for Advanced Therapies (CAT). It is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma (MM), who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, and have demonstrated disease progression on the last therapy. MM is a blood cancer characterized by the malignant proliferation of plasma cells that consistently express the B-cell maturation antigen (BCMA). BCMA is not expressed in normal non-hematopoietic cells. Carvykti is an advanced therapy medicinal product (ATMP) that consists of modified autologous T cells which, upon activation, trigger the cytolytic death of cells that express BCMA.

Recommendations on Extensions of Therapeutic Indication

  • Keytruda (pembrolizumab): extension of indication to include:

    • the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express PD‑L1 with a CPS ≥ 1, in combination with chemotherapy with or without bevacizumab.
    • the treatment, as monotherapy, of the following MSI‑H or dMMR tumours in adults:

      • unresectable or metastatic colorectal cancer after previous fluoropyrimidine‑based combination therapy;
      • advanced or recurrent endometrial carcinoma, who have disease progression on or following prior treatment with a platinum‑containing therapy in any setting and who are not candidates for curative surgery or radiation;
      • unresectable or metastatic gastric, small intestine, or biliary cancer, who have disease progression on or following at least one prior therapy.

    Keytruda had previously been authorised for the treatment of melanoma, non-small cell lung cancer, classical Hodgkin lymphoma, urothelial cancer, head and neck squamous cell carcinoma, renal cell carcinoma, colorectal cancer, oesophageal carcinoma, triple-negative breast cancer and endometrial carcinoma.

  • Kymriah (tisagenlecleucel): extension of indication to include the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. Kymriah had previously been authorised for the treatment of B-cell acute lymphoblastic leukaemia and diffuse large B-cell lymphoma.
  • Polivy (polatuzumab vedotin): extension of indication to include the treatment, in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone, of adult patients with previously untreated diffuse large B-cell lymphoma.

Newly Published EPARs

The EPAR – the European Public Assessment Report – is the main document where the EMA publishes the detailed information from the medicines assessed by the CHMP.

  • Apexxnar (pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed)): indicated for the active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older.
  • Regkirona (regdanvimab): indicated for the treatment of adults with coronavirus disease 2019 (COVID-19) who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.
  • Vaxneuvance (pneumococcal polysaccharide conjugate vaccine (adsorbed)): indicated for active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older

Recently Started Marketing Authorisation Procedure

Every month, new medicinal products are submitted to the EMA for marketing authorisation, with the aim of providing patients with new treatment options for various diseases. The CHMP carries out a scientific assessment of the applications and makes a recommendation.

  • Ublituximab: Treatment of relapsing forms of multiple sclerosis.
  • Tremelimumab: Treatment of adults with metastatic non-small cell lung cancer with no sensitising epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) genomic tumour aberrations.

CHMP Meeting Highlights February 2022

New Medicines Recommended for Authorisation

  • Padcev (enfortumab vedotin): as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a programmed death receptor-1 or programmed death-ligand 1 inhibitor. The CHMP had adopted a positive opinion in December 2021 for Padcev (see the CHMP Highlights for December 2021). New safety information emerged during the decision-making process. Following a request from the European Commission and after assessing the new safety information, the CHMP readopted its positive opinion in February 2022.
  • PreHevbrio (Hepatitis B vaccine [recombinant, adsorbed]): is indicated for active immunisation against infection caused by all known subtypes of the hepatitis B virus (HBV) in adults. HBV causes hepatitis, an inflammation of the liver, which can become chronic and, ultimately, lead to cirrhosis and hepatocellular carcinoma. Despite available vaccines, hepatitis caused by HBV remains a global health problem. Adults who were not vaccinated during childhood remain at risk of becoming infected and up to 10% of adults fail to achieve seroprotective levels with the current vaccination schedule. PreHevbrio is a recombinant vaccine produced by expression of the HBV surface antigen in mammalian cells. The generated particles resemble the naturally occurring viral particles, conferring PreHevbrio with an increased immunogenicity as compared to existing yeast-derived vaccines.

Recommendations on Extensions of Therapeutic Indication

  • Beovu (brolucizumab): extension of indication to include the treatment of visual impairment due to diabetic macular oedema. Beovu had been previously authorised for the treatment of neovascular (wet) age related macular degeneration.
  • Opdivo (nivolumab): has received an authorisation for several extensions of indication:

    • as monotherapy, for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (MIUC) with tumour cell PD-L1 expression ≥ 1%, who are at high risk of recurrence after undergoing radical resection of MIUC.
    • in combination with fluoropyrimidine- and platinum-based combination chemotherapy, for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1%.
    • in combination with ipilimumab, for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1%.

    Opdivo had previously been authorised for the treatment of melanoma, non-small cell lung cancer, malignant pleural mesothelioma, renal cell carcinoma, classical Hodgkin lymphoma, squamous cell cancer of the head and neck, colorectal cancer and gastric, gastro-oesophageal junction or oesophageal adenocarcinoma.

  • Spikevax (COVID-19 mRNA vaccine [nucleoside-modified]): extension of indication to include the active immunisation to prevent COVID-19 caused by SARS-CoV-2 in children 6 to 11 years of age. For more information, see the EMA press release on Spikevax.
  • Yervoy (ipilimumab): extension of indication to include the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1%, in combination with nivolumab. Yervoy had previously been authorised for the treatment of melanoma, renal cell carcinoma, non-small cell lung cancer, malignant pleural mesothelioma and colorectal cancer.

Newly Published EPARs

The EPAR – the European Public Assessment Report – is the main document where the EMA publishes the detailed information from the medicines assessed by the CHMP.

  • Rybrevant (amivantamab) is indicated for treatment of adult patients with advanced non-small cell lung cancer.
  • Saphnelo (anifrolumab) is indicated as an add-on therapy for the treatment of adult patients with systemic lupus erythematosus.
  • Vyepti (eptinezumab) is indicated for the prophylaxis of migraine in adults.

Recently Started Marketing Authorisation Procedure

Every month, new medicinal products are submitted to the EMA for marketing authorisation, with the aim of providing patients with new treatment options for various diseases. The CHMP carries out a scientific assessment of the applications and makes a recommendation.

  • Tabelecleucel (Orphan): ATMP (advanced therapy medicinal product) for the treatment of Epstein-Barr virus positive post-transplant lymphoproliferative disease.
  • Nvx-CoV2373: Prevention of COVID-19
  • Sotrovimab: Treatment of COVID-19

CHMP Meeting Highlights January 2022

New Medicines Recommended for Authorisation

  • Breyanzi (lisocabtagene maraleucel) received a positive opinion based on an assessment by EMA’s Committee for Advanced Therapies (CAT) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), after two or more lines of systemic therapy. DLBCL, PMBCL and FL3B are subtypes of large B-cell lymphomas, and represent approximately 80 %, 3 % and 1 % of all non-Hodgkin lymphomas, respectively. These types of lymphomas can be classified as indolent or aggressive. The latter can be fatal within a short period of time. Breyanzi consists of modified autologous T cells. Remarkably, the single WHO INN “lisocabtagene maraleucel” includes two “active substances”, CD8+ and CD4+ T cells (lentiviral-transduced anti CD19), which trigger the cytolytic death of B-lineage cells expressing the antigen CD19. Breyanzi is considered an advanced therapy medicinal product (ATMP).

Recommendations on Extensions of Therapeutic Indication

  • Dupixent (dupilumab): extension of indication as add-on maintenance treatment of children 6 to 11 years old with severe asthma with type 2 inflammation characterised by raised blood eosinophils and/or raised fraction of exhaled nitric oxide and inadequately controlled with medium to high dose inhaled corticosteroids plus another medicinal product for maintenance treatment. Dupixent has previously been approved for this in indication in adults and adolescents 12 years and older. Dupixent is already approved for the treatment of atopic dermatitis and chronic rhinosinusitis with nasal polyposis.

Newly Published EPARs

The EPAR – the European Public Assessment Report – is the main document where the EMA publishes the detailed information from the medicines assessed by the CHMP.

  • Nuvaxovid [COVID-19 Vaccine (recombinant, adjuvanted)] is indicated for active immunisation to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 in individuals 18 years of age and older.
  • Xevudy (sotrovimab) is indicated for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40 kg) with COVID-19 who do not require oxygen supplementation and who are at increased risk of progressing to severe COVID-19.

Recently Started Marketing Authorisation Procedure

Every month, new medicinal products are submitted to the EMA for marketing authorisation, with the aim of providing patients with new treatment options for various diseases. The CHMP carries out a scientific assessment of the applications and makes a recommendation.

  • Loncastuximab tesirine (Orphan): Treatment of adult patients with relapsed or refractory large B-cell lymphoma.
  • Mosunetuzumab: Treatment of refractory follicular lymphoma.
  • Spesolimab: Treatment of flares in adult patients with generalised pustular psoriasis.
  • Sutimlimab (Orphan): Treatment of haemolysis in adult patients with cold agglutinin disease.

2021

CHMP Meeting Highlights December 2021

New Medicines Recommended for Authorisation

  • Apexxnar (pneumococcal polysaccharide conjugate vaccine [20-valent, adsorbed]) is indicated as active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older. Invasive disease and pneumonia caused by an infection with S. pneumoniae result in high morbidity and mortality, especially in the elderly and in patients with comorbidities or immunocompromised. Apexxnar is a conjugate vaccine that contains pneumococcal polysaccharides from 20 serotypes, conjugated to a carrier protein from Corynebacterium diphtheriae. This conjugation induces a T-cell dependent immune response.
  • Padcev (enfortumab vedotin) as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer (UC) who have previously received a platinum-containing chemotherapy and a programmed death receptor‑1 (PD-1) or programmed death‑ligand 1 (PD-L1) inhibitor. Urothelial cancer is an aggressive cancer of the bladder or other parts of the urinary tract. Padcev is an antibody-drug conjugate that binds Nectin-4 on the cell surface, forming a complex which is subject to endocytosis. The cleavage of Padcev within the lysosomes releases the drug portion of the conjugate, monomethyl auristatin E, which blocks the polymerisation of tubulin and triggers a cascade of events that culminate in cellular apoptosis. Nectin-4 is expressed by the vast majority of UCs. Although more predictive factors for UC are still being studied, the presence of elevated levels of expression of the adhesion protein Nectin-4 seem to be associated with disease progression and poor prognosis in UC and other cancers.
  • Saphnelo (anifrolumab) is indicated as an add-on therapy for the treatment of adult patients with moderate to severe, active autoantibody-positive systemic lupus erythematosus (SLE), despite standard therapy. SLE is a multifactorial chronic and multi-systemic autoimmune disease with varied clinical manifestations, although arthritis and photosensitive skin rash are common symptoms. The aetiology of SLE is unknown, although genetic, environmental and hormonal factors are believed to play important roles. The type I interferon cytokine family regulates several immune functions and cellular components. In SLE, several interferon-regulated genes are over-expressed. Anifrolumab is a monoclonal antibody which binds to anti-type I interferon receptor (IFNAR1) and inhibits the binding of type I interferons to their receptor, thereby blocking their activity.
  • Xevudy (sotrovimab) is indicated for the treatment of COVID-19 in adults and adolescents (from 12 years of age and weighing at least 40 kilograms) who do not require supplemental oxygen and who are at increased risk of the disease becoming severe. COVID-19 or Coronavirus disease 2019, is a contagious disease caused by the Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Although this virus can infect a wide variety of cells, it is most known for causing respiratory tract symptoms, which vary from mild to severe. The virus enters the cells mainly by binding to the angiotensin converting enzyme 2 (ACE2). Xevudy is a monoclonal antibody that binds to a highly conserved region of the receptor-binding domain (RBD) of the Spike protein of the SARS‑CoV-2 virus. Although Xevudy does not impede the attachment to ACE2, it blocks the entry of the virus into the cells and hinders infection. The majority of patients in the study were infected with the original SARS-CoV-2 virus. Some patients were infected with variants including Alpha and Epsilon. Findings from laboratory studies indicate that Xevudy is also expected to be effective against other variants (including Omicron).

Recommendations on Extensions of Therapeutic Indication

  • Entyvio (vedolizumab): extension of indication to the treatment of adult patients with moderately to severely active chronic pouchitis, who have undergone proctocolectomy and ileal pouch anal anastomosis for ulcerative colitis, and have had an inadequate response with or lost response to antibiotic therapy. Entyvio is already authorised for the treatment of ulcerative colitis and Crohn’s disease.
  • Keytruda (pembrolizumab): extension of indication for Keytruda as monotherapy, to the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions. Keytruda is already authorised for the treatment of melanoma, non-small cell lung carcinoma, classical Hodgkin lymphoma, urothelial carcinoma, head and neck squamous cell carcinoma, renal cell carcinoma, colorectal cancer, oesophageal carcinoma, triple-negative breast cancer and endometrial carcinoma.

Newly Published EPARs

The EPAR – the European Public Assessment Report – is the main document where the EMA publishes the detailed information from the medicines assessed by the CHMP.

  • Trodelvy (sacituzumab govitecan): for the treatment of triple-negative breast cancer.

Recently Started Marketing Authorisation Procedure

Every month, new medicinal products are submitted to the EMA for marketing authorisation, with the aim of providing patients with new treatment options for various diseases. The CHMP carries out a scientific assessment of the applications and makes a recommendation.

  • Relatlimab / nivolumab: for the first-line treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents (12 years and older and weighing at least 40 kg).

CHMP Meeting Highlights November 2021

New Medicines Recommended for Authorisation

  • Regkirona (regdanvimab) is indicated for the treatment of adults with coronavirus disease 2019 (COVID-19) who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.
  • Ronapreve (casirivimab / imdevimab) is indicated for:

    • Treatment of COVID-19 in adults and adolescents aged 12 years and older weighing at least 40 kg who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.
    • Prevention of COVID-19 in adults and adolescents aged 12 years and older weighing at least 40 kg.

    COVID-19 or Coronavirus disease 2019 is a contagious disease caused by the SARS‑CoV‑2 virus (Severe acute respiratory syndrome coronavirus 2). Although this virus can infect a wide variety of cells, it is most known for causing respiratory tract symptoms, which vary from mild to severe. The virus enters the cells mainly by binding to the angiotensin converting enzyme 2 (ACE2). Regkirona and Ronapreve bind to the receptor-binding domain (RBD) of the Spike protein of the SARS‑CoV‑2 virus, thereby impeding its attachment to ACE2. This blocks the entry of the virus into the cells and hinders infection. Regkirona and Ronapreve are the first monoclonal antibodies to receive a positive opinion by the CHMP for the treatment of COVID-19.

    Based on the CHMP recommendations, the European Commission has already granted marketing authorisations for Regkirona and Ronapreve.

  • Uplizna (inebilizumab) is indicated as monotherapy for the treatment of adult patients with neuromyelitis optica spectrum disorders (NMOSD) who are anti-aquaporin 4 immunoglobulin G (AQP4-IgG) seropositive. NMOSD is a rare and chronic autoimmune syndrome of heterogeneous aetiology, which manifests with acute inflammation of the optic nerve and spinal cord. AQP4 is expressed in astrocytes and it is the most abundant water channel in the central nervous system. AQP4-IgGs are detected in 80-90% of patients and cause astrocyte loss by antibody-mediated immune responses, although the mechanism is not fully understood. Uplizna is a monoclonal antibody that binds to a specific surface antigen of the B-cells, which results in a depletion of these cells, thereby suppressing the immune response.
  • Vyepti (eptinezumab) is indicated for the prophylaxis of migraine in adults who have at least four migraine days per month. Migraine is a chronic condition characterised by recurrent headaches that may affect quality of life and productivity. Although the causes of migraine are unknown, calcitonin gene-related peptides (CGRPs) have been found to be involved in the development of pain in migraine. Vyepti is an anti-CGRP monoclonal antibody that is administered intravenously. By binding to CGRP, it prevents the development of the cascade of events that result in a migraine attack.

Recommendations on Extensions of Therapeutic Indication

  • Dengvaxia (dengue tetravalent vaccine, live and attenuated): extension of indication to the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3 and 4 in individuals 6 to 45 years of age with test-confirmed previous dengue infection.

Newly Published EPARs

The EPAR – the European Public Assessment Report – is the main document where the EMA publishes the detailed information from the medicines assessed by the CHMP.

  • Regkirona (regdanvimab) (for indication see above "New Medicines Recommended for Authorisation")
  • Ronapreve (casirivimab / imdevimab) (for indication see above "New Medicines Recommended for Authorisation")

CHMP Meeting Highlights October 2021

New Medicines Recommended for Authorisation

  • Rybrevant (amivantamab) received a positive opinion for a conditional marketing authorisation (CMA). It is indicated as monotherapy for treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR) Exon 20 insertion mutations, after failure of platinum-based therapy. NSCLC is a serious and often fatal disease that accounts for over 85% of all lung cancers. Although mutations in the EGFR proto-oncogene are common in this setting, only about 10% are insertions in exon 20. Approved tyrosine kinase inhibitors (TKIs) cannot bind and inhibit the resulting aberrant proteins, rendering the arising tumours resistant to these TKIs. Rybrevant is a bispecific antibody targeted against EGFR and MET, although the mechanism by which it inhibits tumours is not fully understood.
  • Trodelvy (sacituzumab govitecan) is indicated as monotherapy for the treatment of adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, including at least one of them for advanced disease. TNBC accounts for around 15% of all invasive breast cancers and it is associated with poor prognosis. These tumours are characterised by a lack of human epidermal growth factor 2 (HER2), oestrogen and progesterone receptor expression, which renders them insensitive to hormonal therapy or HER2-targeted medicines. Trodelvy is a first-in-class antibody-drug conjugate which includes a monoclonal antibody targeted against trophoblast cell surface antigen 2 (Trop-2), covalently bound to the topoisomerase I inhibitor SN-38 through a hydrolysable linker. Since overexpression of Trop-2 is common in malignant tumours, Trodelvy is recruited to the tumour thorough its antibody component. The SN-38 component is then released, intra- and extracellularly, upon hydrolysis of the linker.
  • Vaxneuvance (pneumococcal polysaccharide conjugate vaccine, 15-valent, adsorbed) is indicated for active immunisation for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae in individuals 18 years of age and older. Invasive disease and pneumonia caused by an infection with S. pneumoniae result in high morbidity and mortality, especially in the elderly and in patients with comorbidities or immunocompromised. Vaxneuvance is a conjugate vaccine that contains pneumococcal polysaccharides from 15 serotypes, conjugated to a carrier protein from Corynebacterium diphtheriae.

Recommendations on Extensions of Therapeutic Indication

  • Hizentra (human normal immunoglobulin, SCIg): The indication has been updated. Hizentra is now indicated as replacement therapy for the treatment of secondary immunodeficiencies in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure or serum IgG level of < 4 g/l. Hizentra is also approved as replacement therapy for primary immunodeficiency syndromes and as immunomodulatory therapy for chronic inflammatory demyelinating polyneuropathy.
  • Keytruda (pembrolizumab):

    • Extension of indication to include, in combination with lenvatinib, the first‑line treatment of advanced renal cell carcinoma in adults. Keytruda is also authorised, in combination or as monotherapy, for the treatment of melanoma, non-small cell lung carcinoma, classical Hodgkin lymphoma, urothelial carcinoma, head and neck squamous cell carcinoma, renal cell carcinoma, colorectal cancer and oesophageal carcinoma.
    • Extension of indication to include, in combination with lenvatinib, the treatment of advanced or recurrent endometrial carcinoma in adults who have disease progression on or following prior treatment with a platinum‑containing therapy in any setting and who are not candidates for curative surgery or radiation.
  • Repatha (evolocumab): extension of indication to include the treatment of paediatric patients aged 10 years and over with homozygous or heterozygous familial hypercholesterolaemia. Repatha alone or in combination is also indicated for the treatment of established atherosclerotic cardiovascular disease and mixed dyslipidaemia.
  • Skyrizi (risankizumab): extension of indication to include, alone or in combination with methotrexate, the treatment of active psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to one or more disease-modifying antirheumatic drugs. Skyrizi had previously also been authorised for the treatment of plaque psoriasis.

Recently Started Marketing Authorisation Procedure

Every month, new medicinal products are submitted to the EMA for marketing authorisation, with the aim of providing patients with new treatment options for various diseases. The CHMP carries out a scientific assessment of the applications and makes a recommendation.

  • Valoctocogene roxaparvovec: orphan, advanced therapy medicinal product (ATMP), treatment of severe haemophilia A.

CHMP Meeting Highlights September 2021

New Medicines Recommended for Authorisation

The CHMP recommended two biosimilar medicines for marketing authorisation:

  • Hukyndra and Libmyris (both containing adalimumab): for the treatment of inflammatory autoimmune disorders such as arthritis psoriasis, inflammatory bowel disease or uveitis.

A biosimilar medicine is a biological medicine that is highly similar to another biological medicine that is already authorised for use.

Recommendations on Extensions of Therapeutic Indication

  • Keytruda (pembrolizumab): extension of indication to include, in combination with chemotherapy, the treatment of locally recurrent unresectable or metastatic triple negative breast cancer in adults whose tumours express PD-L1 with a CPS ≥ 10 and who have not received prior chemotherapy for metastatic disease. Keytruda had previously been authorised for the treatment of melanoma, non-small cell lung carcinoma, classical Hodgkin lymphoma, urothelial carcinoma, head and neck squamous cell carcinoma, renal cell carcinoma, colorectal cancer and oesophageal carcinoma.
  • Nucala (mepolizumab): extension of indication to include Nucala as an add-on the treatment of:

    • Patients aged 6 years and older with relapsing-remitting or refractory eosinophilic granulomatosis with polyangiitis;
    • Adult patients with inadequately controlled hypereosinophilic syndrome without an identifiable non-haematologic secondary cause;
    • Adult patients with severe Chronic Rhinosinusitis with Nasal Polyposis (CRSwNP ) for whom therapy with systemic corticosteroids and/or surgery do not provide adequate disease control (add-on therapy with intranasal corticosteroids).

Nucala had previously been authorised for the treatment of eosinophilic asthma.

  • Opdivo (nivolumab): extension of indication in combination with fluoropyrimidine- and platinum-based combination chemotherapy, for the first‑line treatment of adult patients with HER2‑negative advanced or metastatic gastric, gastro‑oesophageal junction or oesophageal adenocarcinoma whose tumours express PD-L1 with a combined positive score (CPS) ≥ 5. Opdivo had previously been authorised for the treatment of melanoma, non-small cell lung cancer, malignant pleural mesothelioma, renal cell carcinoma, classical Hodgkin lymphoma, squamous cell cancer of the head and neck, urothelial carcinoma, mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal cancer and oesophageal squamous cell carcinoma.

Newly Published EPARs

  • Bimzelx (bimekizumab): for the treatment of plaque psoriasis.
  • Byooviz (ranibizumab): for the treatment of ‘wet’ form of age-related macular degeneration, macular oedema, proliferative diabetic retinopathy and other sight problems associated with choroidal neovascularisation.
  • Minjuvi (tafasitamab): for the treatment of diffuse large B-cell lymphoma.

Recently Started Marketing Authorisation Procedure

Every month, new medicinal products are submitted to the EMA for marketing authorisation, with the aim of providing patients with new treatment options for various diseases. The CHMP carries out a scientific assessment of the applications and makes a recommendation.

  • Tezepelumab: add-on maintenance treatment in adults and adolescents 12 years and older with severe asthma.
  • Faricimab: treatment of neovascular (wet) age-related macular degeneration and visual impairment due to diabetic macular oedema.

COVID-19: CHMP concludes Article 5(3) review on Vaxzevria

The article 5(3) of the European Regulation 726/2004 states that, “At the request of the Executive Director of the Agency or the Commission representative, the Committee for Medicinal Products for Human Use shall also draw up an opinion on any scientific matter concerning the evaluation of medicinal products for human use. The Committee shall take due account of any requests by Member States for an opinion. The Committee shall also formulate an opinion whenever there is disagreement in the evaluation of medicinal products through the mutual recognition procedure. The opinion of the Committee shall be made publicly accessible”.

A scientific opinion was requested by the European Commission following the initial reports of thrombosis with thrombocytopenia syndrome (TTS) associated with this vaccine. The CHMP has concluded the analysis of data on the risk of TTS and on the use of a second dose of Vaxzevria:

  • The evidence did not allow identifying particular risk factors that make TTS more likely.
  • EMA’s recommendation remains to continue giving a second dose of Vaxzevria between 4 and 12 weeks after the first, in line with the product information.
  • There is no evidence that delaying the second dose has any influence on the risk of TTS.
  • No definitive recommendations on the use of a different vaccine for the second dose can be made at present.

CHMP Meeting Highlights July 2021

Recommendations on Extensions of Therapeutic Indication

  • Ultomiris (ravulizumab) extension of indication to include the treatment of paediatric patients with a body weight of 10 kg or above.

Recently Started Marketing Authorisation Procedure

Every month, new medicinal products are submitted to the EMA for marketing authorisation, with the aim of providing patients with new treatment options for various diseases. The CHMP carries out a scientific assessment of the applications and makes a recommendation.

  • Ciltacabtagene autoleucel: treatment of multiple myeloma.
  • Omburtamab I-131: treatment of neuroblastoma.
  • Ranibizumab: treatment of neovascular age-related macular degeneration in adults.

Referral Procedures

A referral is a procedure in which EMA is asked to evaluate scientifically a medicine or class of medicines on behalf of the European Union. These type of procedures are intended to resolve certain safety or benefit-risk balance concerns.

Conclusion of the referral on Zynteglo: CHMP has endorsed a review that found no link between the viral vector and acute myeloid leukaemia (AML):

  • Although two patients who received the same viral vector in another medicine had AML, there are more plausible explanations than insertional oncogenesis, including the conditioning treatment the patients received and the higher risk of haematological cancer in people with sickle cell disease.
  • Healthcare professionals should explicitly inform patients receiving Zynteglo of the increased risk of blood cancers from medicines used in conditioning treatments.
  • Healthcare professionals should continue monitoring patients for cancer. EMA has updated its recommendation for cancer screening, changing the requirement from once a year to at least once a year.

CHMP Meeting Highlights June 2021 (German only)

Neue biomedizinische Arzneimittel zur Zulassung empfohlen

  • Abecma (Idecabtagene Vicleucel) dient zur Behandlung erwachsener Patientinnen und Patienten mit rezidiviertem und refraktärem multiplem Myelom (MM), die mindestens drei vorangegangene Therapien erhalten haben, darunter einen immunmodulierenden Wirkstoff, einen Proteasom-Inhibitor und einen Anti-CD38-Antikörper, und deren Krebserkrankung sich seit der letzten Behandlung verschlimmert hat. MM ist ein Blutkrebs, der durch die bösartige Vermehrung von Plasmazellen gekennzeichnet ist, welche durchgängig das B-Zell-Reifungsantigen (BCMA) exprimieren. BCMA wird in normalen nicht hämatopoetischen Zellen nicht exprimiert. Abecma ist ein Gentherapieprodukt, das aus modifizierten autologen T-Zellen besteht, die bei Aktivierung den zytolytischen Tod von Zellen auslösen, welche BCMA exprimieren.
  • Bimzelx (Bimekizumab) zur Behandlung von mittelschwerer bis schwerer Plaque-Psoriasis. Psoriasis ist eine häufige chronisch-entzündliche Hauterkrankung mit unterschiedlichen klinischen Phänotypen, wobei 80 bis 90% der Patientinnen und Patienten von Plaque-Psoriasis betroffen sind. Die Plaque-Psoriasis ist durch erhabene, scharf abgegrenzte, erythematöse Plaques gekennzeichnet, die von silbrigen Schuppen bedeckt sind. Bimzelx ist ein gegen Interleukin 17-A und 17-F gerichteter monoklonaler Antikörper, der die Entzündungsreaktion des Körpers durch Neutralisierung dieser Zytokine reduziert.
  • Byooviz (Ranibizumab) zur Behandlung

    • der neovaskulären (feuchten) altersbedingten Makuladegeneration,
    • der Sehbeeinträchtigung aufgrund eines diabetischen Makulaödems,
    • der proliferativen diabetischen Retinopathie,
    • der Sehbeeinträchtigung aufgrund eines Makulaödems als Folge eines Netzhautvenenverschlusses (Zweig-RVO oder Zentral-RVO) und
    • der Sehbeeinträchtigung aufgrund einer choroidalen Neovaskularisation.

    Der vaskuläre endotheliale Wachstumsfaktor A (VEGF-A) ist das Hauptprotein, das für das Auslösen des Wachstums von Blutgefäßen verantwortlich ist. Es wird daher angenommen, dass dieser zur Pathophysiologie von Krankheiten beiträgt, die Blutgefäße betreffen, wie die oben genannten Indikationen. Byooviz ist ein monoklonaler Antikörper, der den VEGF-A-Signalweg hemmt, indem er die Bindung an VEGF-A blockiert. Byooviz ist ein Biosimilar Arzneimittel zu Lucentis.

  • Minjuvi (Tafasitamab) erhielt eine Empfehlung für eine bedingte Marktzulassung zur Behandlung erwachsener Patienten mit rezidiviertem oder refraktärem diffus-großzelligem B-Zell-Lymphom (DLBCL), die nicht für eine autologe Stammzelltransplantation (ASCT) in Frage kommen. DLBCL ist eine aggressive Krebserkrankung der B-Lymphozyten und die häufigste Form des Non-Hodgkin-Lymphoms. Minjuvi ist ein monoklonaler Antikörper, der an das CD19-Oberflächenantigen von B-Zellen bindet, was zu einem Antikörper-induzierten Zelltod führt.

Empfehlungen zur Erweiterung der therapeutischen Indikation

  • Opdivo (Nivolumab): Erweiterung der Indikation als Monotherapie, auf die adjuvante Behandlung erwachsener Patienten mit Speiseröhrenkrebs oder Krebs des gastroösophagealen Übergangs, die nach einer vorherigen neoadjuvanten Chemoradiotherapie einen pathologischen Restbefund aufweisen. Opdivo ist bereits, in Kombination oder als Monotherapie, für die Behandlung von Melanom, nicht-kleinzelligem Lungenkrebs, malignem Pleuramesotheliom, Nierenzellkarzinom, klassischem Hodgkin-Lymphom , Plattenepithelkarzinom des Kopfes und Halses, Urothelkarzinom, Plattenepithelkarzinom der Speiseröhre und Dickdarmkrebs zugelassen.

CHMP Meeting Highlights May 2021 (German only)

Empfehlungen zur Erweiterung der therapeutischen Indikation

  • Blincyto (Blinatumomab): Erweiterung der Indikation als Monotherapie auf die Behandlung von pädiatrischen Patientinnen und Patienten im Alter von 1 Jahr oder älter mit Hochrisiko-Erstrezidiv einer Philadelphia-Chromosom-negativen CD19-positiven akuten B-Vorläufer-Lymphoblasten-Leukämie (ALL) im Rahmen der Konsolidierungstherapie.
  • Darzalex (Daratumumab): Erweiterung der Indikation in Kombination mit Pomalidomid und Dexamethason auf die Behandlung erwachsener Patientinnen und Patienten mit multiplem Myelom, die eine vorherige Therapie mit einem Proteasom-Inhibitor und Lenalidomid erhalten haben und Lenalidomid-refraktär waren oder die mindestens zwei vorherige Therapien mit Lenalidomid und einem Proteasom-Inhibitor erhalten haben und bei oder nach der letzten Therapie ein Fortschreiten der Erkrankung zeigten.
  • Darzalex (Daratumumab): Erweiterung der Indikation in Kombination mit Cyclophosphamid, Bortezomib und Dexamethason auf die Behandlung erwachsener Patientinnen und Patienten mit neu diagnostizierter systemischer Leichtketten-Amyloidose (ALL).
  • Keytruda (Pembrolizumab): Erweiterung der Indikation in Kombination mit Platin- und Fluoropyrimidin-basierter Chemotherapie auf die Erstlinienbehandlung von Patientinnen und Patienten mit lokal fortgeschrittenem inoperablem oder metastasiertem Karzinom der Speiseröhre oder HER-2-negativem Adenokarzinom des gastroösophagealen Übergangs bei Erwachsenen, deren Tumoren PD-L1 mit einem CPS ≥ 10 exprimieren. Keytruda war zuvor in Kombination oder als Monotherapie für die Behandlung von Melanom, nicht kleinzelligem Lungenkarzinom, klassischem Hodgkin-Lymphom, Urothelkarzinom, Plattenepithelkarzinom im Kopf- und Halsbereich, Nierenzellkarzinom und Darmkrebs zugelassen worden.
  • Libtayo (Cemiplimab): Erweiterung der Indikation als Monotherapie auf die Behandlung erwachsener Patientinnen und Patienten mit lokal fortgeschrittenem oder metastasiertem Basalzellkarzinom, die nicht auf einen Hedgehog-Pathway-Inhibitor (HHI) angesprochen haben oder diesen nicht vertragen.
  • Libtayo (Cemiplimab): Erweiterung der Indikation auf die Erstlinienbehandlung erwachsener Patientinnen und Patienten mit nicht kleinzelligem Lungenkarzinom (NSCLC), das PD-L1 exprimiert (in ≥ 50% der Tumorzellen) ohne EGFR-, ALK- oder ROS1-Aberrationen, mit lokal fortgeschrittenem NSCLC, die keine Kandidaten für eine definitive Chemobestrahlung sind, oder metastasiertem NSCLC.
  • Opdivo (Nivolumab): Erweiterung der Indikation, in Kombination mit Ipilimumab, auf die Behandlung erwachsener Patientinnen und Patienten mit Mismatch-Reparatur-defizientem oder mikrosatelliteninstabilem metastasiertem kolorektalen Karzinom nach vorheriger Fluoropyrimidin-basierter Kombinationschemotherapie. Opdivo war zuvor in Kombination oder als Monotherapie für die Behandlung von Melanom, nicht kleinzelligem Lungenkrebs (NSCLC), malignem Pleuramesotheliom (MPM), Nierenzellkarzinom (RCC), klassischem Hodgkin-Lymphom (cHL), Plattenepithelkarzinom des Kopfes und Halses (SCCHN), Urothelkarzinom und Plattenepithelkarzinom des Ösophagus (OSCC) zugelassen worden.
  • Spherox (Sphäroide aus humanen autologen matrixassoziierten Chondrozyten): Erweiterung der Indikation auf die Behandlung von Jugendlichen mit geschlossener epiphysärer Wachstumsplatte im betroffenen Gelenk.
  • Yervoy (Ipilimumab): Erweiterung der Indikation, in Kombination mit Nivolumab, auf die Behandlung erwachsener Patientinnen und Patienten mit Mismatch-Reparatur-defizientem oder mikrosatelliteninstabilem metastasiertem kolorektalen Karzinom nach vorheriger Fluoropyrimidin-basierter Kombinationschemotherapie. Yervoy war zuvor in Kombination oder als Monotherapie für die Behandlung von Melanom, nicht-kleinzelligem Lungenkrebs (NSCLC), malignem Pleuramesotheliom (MPM) und Nierenzellkarzinom (RCC) zugelassen worden.

Neu veröffentlichte EPARs

Der Europäische Öffentliche Beurteilungsbericht (European Public Assessment Report, EPAR) ist das Hauptdokument, in dem die EMA-Geschäftsstelle detaillierte Informationen über die vom CHMP bewerteten Arzneimittel veröffentlicht.

  • Jemperli (Dostarlimab) zur Behandlung von Endometriumkarzinom.
  • Alymsys (Bevacizumab) zur Behandlung von Dickdarmkrebs, Brustkrebs, nicht kleinzelligem Lungenkrebs (NSCLC), Nierenzellkarzinom, Eierstock- oder Eileiterkrebs und Gebärmutterhalskrebs.

Kürzlich gestartete Zulassungsverfahren

Jeden Monat werden bei der EMA-Geschäftsstelle neue Arzneimittel zur Zulassung eingereicht, die Patientinnen und Patienten neue Therapiemöglichkeiten für verschiedene Erkrankungen eröffnen sollen. Der CHMP nimmt eine wissenschaftliche Bewertung der Anträge vor und gibt eine Empfehlung ab.

  • Tetravalenter Dengue-Impfstoff (lebend, abgeschwächt), gemäß Artikel 58: Prävention der Dengue-Krankheit.
  • Tetravalenter Dengue-Impfstoff (lebend, abgeschwächt): Prävention der Dengue-Krankheit.
  • Oportuzumab monatox: Behandlung und Rezidivprophylaxe von Carcinoma-in-situ der Harnblase und Rezidivprophylaxe von hochgradigen Ta- oder T1-Papillartumoren.
  • Enfortumab vedotin: Behandlung des lokal fortgeschrittenen oder metastasierten Urothelkarzinoms.
  • Sacituzumab: Govitecan Behandlung von inoperablem lokal fortgeschrittenem oder metastasiertem dreifach negativem Brustkrebs (mTNBC).

Updated: 05.03.2024