Bristol-Myers Squibb Company (BMY) on Friday announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended marketing authorization approval of Abecma (idecabtagene vicleucel; ide-cel).
The company stated that the CHMP's positive opinion is based on the final analysis of progression-free survival (PFS) from the pivotal Phase 3 KarMMa-3 study, where Abecma showed superiority over standard regimens, significantly improved progression-free survival, and a well-established safety profile with mostly low-grade occurrences of cytokine release syndrome and neurotoxicity.
Abecma is for treating adult patients with relapsed and refractory multiple myeloma who have undergone at least two prior therapies, including an immunomodulatory agent (IMiD), a proteasome inhibitor (PI), and an anti-CD38 monoclonal antibody.
The European Commission (EC), responsible for authorizing medicines for the European Union (EU), will evaluate the CHMP recommendation. Furthermore, the approval by the EC would expand Abecma's indication, making it the first CAR T cell therapy available in the EU for patients with triple-class exposed relapsed and refractory multiple myeloma.
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