The Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended granting Conditional Marketing Authorization for Abecma (idecabtagene vicleucel; ide-cel) for the treatment of adult patients with relapsed and refractory multiple myeloma 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.
Abecma, sponsored by Bristol Myers Squibb, is a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor T cell immunotherapy. The CHMP recommendation will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union.
The CHMP adopted a positive opinion based on results from the pivotal Phase 2 KarMMa study evaluating the efficacy and safety of Abecma in 128 patients with heavily pre-treated and highly refractory multiple myeloma.
The EC is expected to deliver its final decision within 67 days of receipt of the CHMP opinion. The decision will be applicable to all European Union member states and Iceland, Norway and Liechtenstein. The EMA previously granted Abecma access to the PRIority MEdicines (PRIME) scheme for the treatment of relapsed and refractory multiple myeloma.
