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CHMP Meeting highlights March 2022 (news for COVID and multiple myeloma treatments)

  • 24 marzo 2022
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EMA’s human medicines committee (CHMP) recommended five medicines for approval at its March 2022 meeting, including the following of interest:

The monoclonal antibody Evusheld (tixagevimab / cilgavimab), developed by AstraZeneca AB, received a positive opinion from the CHMP for the prevention of COVID-19 in adults and adolescents from 12 years of age weighing at least 40 kg before potential exposure to the SARS-CoV-2 virus. Evusheld is made of the active substances tixagevimab and cilgavimab, two monoclonal antibodies designed to attach to the spike protein of the SARS-CoV-2 virus (the virus that causes COVID-19) at two different sites. When the antibodies in Evusheld attach to the spike protein, the virus cannot enter the cells to multiply and is unable to cause COVID-19 infection.

 

A new gene therapy, Carvykti (ciltacabtagene autoleucel), received a positive opinion for a conditional marketing authorisation for the treatment of adult patients with relapsed and refractory multiple myeloma (MM) who have received at least three prior therapies and whose cancer has worsened since they received their last treatment. Carvykti had support through the PRIME scheme, EMA’s platform for early and enhanced dialogue with developers of promising new medicines that address unmet medical needs.

 

Kymriah (by Novartis) received a positive opinion recommending a new indication for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. The full indications for Kymriah will therefore be as follows:

  • Paediatric and young adult patients up to and including 25 years of age with B‑cell acute lymphoblastic leukaemia (ALL) that is refractory, in relapse post‑transplant or in second or later relapse.
  • Adult patients with relapsed or refractory diffuse large B‑cell lymphoma (DLBCL) after two or more lines of systemic therapy.
  • Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

 

Polivy (by Roche) received positive opinion for the new indication for the treatment of previously untreated diffuse large B-cell lymphoma. The full indications for Polivy will be as follows:

Polivy in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) is indicated for the treatment of adult patients with previously untreated diffuse large B-cell lymphoma (DLBCL).

Polivy in combination with bendamustine and rituximab is indicated for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are not candidates for haematopoietic stem cell transplant.

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