CHMP Meeting Highlights March 2022

This month, medicinal products for the following indications have received a positive opinion:

• COVID-19 prophylaxis
• Multiple myeloma

New medicines recommended for approval:

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 need still exists 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. EMA press release on Evusheld. For more information please consult the product page for Evusheld on the EMA website.

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. EMA press release on Carvykti. For more information please consult the product page for Carvykti on the EMA website.

Recommendations on extensions of therapeutic indication:

Cabometyx (cabozantinib): extension of indication to include, as monotherapy, the treatment of adult patients with locally advanced or metastatic differentiated thyroid carcinoma, refractory or not eligible to radioactive iodine who have progressed during or after prior systemic therapy. Cabometyx had previously been authorised for the treatment of hepatocellular and renal cell carcinoma.
In a different product (Cometriq), the same active substance, cabozantinib, is authorised for the treatment of medullary thyroid carcinoma. Of note, the dose for the treatment of differentiated thyroid carcinoma and medullary thyroid carcinoma is different. Moreover, the two products (Cabometyx and Cometriq) are not bioequivalent and cannot be used interchangeably. For more information please consult the product page for Cabometyx on the EMA website.

Jakavi (ruxolitinib): extension of indication to include the treatment of patients aged 12 years and older with acute graft versus host disease or chronic graft versus host disease who have inadequate response to corticosteroids or other systemic therapies. Jakavi had previously been authorised for the treatment of myelofibrosis and polycythaemia vera. For more information please consult the product page for Jakavi on the EMA website.

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. For more information please consult the product page for Keytruda on the EMA website.

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. For more information please consult the product page for Kymriah on the EMA website.

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. For more information please consult the product page for Polivy on the EMA website.

Newly published EPARs:

The EPAR (European public assessment report) is the main document where the EMA publishes detailed information on the medicines assessed by the CHMP. Below is a list of the EPARs for recently approved products that have been made available on the EMA homepage:

Apexxnar (pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed)): is 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. EPAR Apexxnar.

Gavreto (pralsetinib): is indicated as monotherapy for the treatment of adult patients with rearranged during transfection (RET) fusion-positive advanced non-small cell lung cancer (NSCLC) not previously treated with a RET inhibitor. EPAR Gavreto.

Kerendia (finerenone): is indicated for the treatment of chronic kidney disease (stage 3 and 4 with albuminuria) associated with type 2 diabetes in adults. EPAR Kerendia.

Ngenla (somatrogon): is indicated for the treatment of children and adolescents from 3 years of age with growth disturbance due to insufficient secretion of growth hormone. EPAR Ngenla.

Oxbryta (voxelotor): is indicated for the treatment of haemolytic anaemia due to sickle cell disease in adults and paediatric patients 12 years of age and older as monotherapy or in combination with hydroxycarbamide. EPAR Oxbryta.

Qinlock (ripretinib): is indicated for the treatment of adult patients with advanced gastrointestinal stromal tumour who have received prior treatment with three or more kinase inhibitors, including imatinib. EPAR Qinlock.

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. EPAR Regkirona.

Tavneos (avacopan): in combination with a rituximab or cyclophosphamide regimen, is indicated for the treatment of adult patients with severe, active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis. EPAR Tavneos.

Vaxneuvance (pneumococcal polysaccharide conjugate vaccine (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. EPAR Vaxneuvance.

Voraxaze (glucarpidase): is indicated to reduce toxic plasma methotrexate concentration in adults and children (aged 28 days and older) with delayed methotrexate elimination or at risk of methotrexate toxicity. EPAR Voraxaze.

Vumerity (diroximel fumarate): is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis. EPAR Vumerity.

Wegovy (semaglutide): is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance. EPAR Wegovy.

Recently started procedures:

• Ublituximab - Treatment of relapsing forms of multiple sclerosis.
• Sirolimus - Orphan - Treatment of angiofibroma associated with tuberous sclerosis complex.
• 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.
• Parsaclisib - Orphan - Treatment of adult patients with relapsed or refractory marginal zone lymphoma.
• (1R,2S,5S)-N-((1S)-1-Cyano-2-((3S)-2-oxopyrrolidin-3-yl)ethyl)-3-((2S)-3,3-dimethyl-2-(2,2,2-trifluoroacetamido) butanoyl)-6,6-dimethyl-3-azabicyclo[3.1.0]hexane-2-carboxamide/ ritonavir - Treatment of COVID-19.

Further inquiry note

basg_anfragen@basg.gv.at