Abecma (idecabtagene vicleucel) ottiene opinione positiva dal CHMP per l'impiego in terza linea nel mieloma multiplo

The EMA's CHMP has granted a positive Opinion to BMS' Abecma (idecabtagene vicleucel) for its extension of indication in r/r Multiple Myeloma.

The full indication will reads as follows:

"Abecma is indicated for the treatment of adult patients with relapsed and refractory multiple myeloma who have received at least threetwo prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti CD38 antibody and have demonstrated disease progression on the last therapy."

This approval is based on the data from the pivotal, Phase 3, open-label, global, randomized, controlled KarMMa-3 study evaluating Abecma compared with standard combination regimens in adults with relapsed and refractory multiple myeloma after two to four prior lines of therapy, including an IMiD, a PI, and an anti-CD38 monoclonal antibody, which are the three main classes of therapy (triple-class exposed) in multiple myeloma, and who were refractory to their last regimen.

Results recently presented at the American Society of Hematology (ASH) Annual Meeting in December 2023 showed, at a median follow-up of 30.9 months (range: 12.7-47.8), Abecma significantly improved PFS compared with standard regimens, with a median PFS of 13.8 months vs. 4.4 months (HR:0.49; 95% CI: 0.38-0.63), representing a 51% reduction in the risk of disease progression or death with Abecma.

Reference link: Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 January 2024; Abecma Summary of Opinion; BMS press release