On Friday, Bristol-Myers Squibb Company announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) is recommending approval for the marketing authorization of Abecma (idecabtagene vicleucel; ide-cel).
This positive opinion from the CHMP builds on the final analysis of progression-free survival (PFS) from the ground-breaking Phase 3 KarMMa-3 study. This study demonstrated that Abecma outperformed standard regimens in terms of significantly improved progression-free survival, and showcased an established safety profile with predominantly low-grade incidents of cytokine release syndrome and neurotoxicity.
Abecma is prescribed for the treatment of adult patients with relapsed and refractory multiple myeloma. These patients must have undergone a minimum of two prior therapies including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
The next step in this process is the evaluation of the CHMP's recommendation by the European Commission (EC), who are responsible for authorizing medicines for distribution across the European Union. If the EC approves this recommendation, Abecma's indication will be broadened, making it the first CAR T cell therapy to be made available to patients with triple-class exposed relapsed and refractory multiple myeloma within the EU.
