Benzinga | Jun 25, 2021 06:55AM EDT

Bristol Myers Reports Positive CHMP Opinion For Anti-B-Cell Mutation Antigen CAR T Cell Therapy Abecma For Relapsed, Refractory Multiple Myeloma

Recommendation for approval based on results from pivotal KarMMa study

Abecma is the first CAR T cell therapy for adults with relapsed and refractory multiple myeloma to receive positive CHMP opinion and builds on the company's innovative and leading portfolio across the disease

PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE:BMY) today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended granting Conditional Marketing Authorization for Abecma (idecabtagene vicleucel; ide-cel), the company's B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy, 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. The CHMP recommendation will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU).

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.

"As the first CAR T cell therapy for relapsed and refractory multiple myeloma to receive a positive CHMP opinion, Abecma represents a potential new treatment approach for patients in Europe battling this incurable blood cancer," said Noah Berkowitz, M.D., Ph.D., senior vice president, Cellular Therapy Development, Bristol Myers Squibb. "We look forward to the European Commission's decision as we build on our innovative multiple myeloma and cell therapy research to offer novel and personalized treatment options for patients in need."

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.