FDA approves first anti-BCMA CAR T cell therapy for relapsed/refractory multiple myeloma

The U.S. Food and Drug Administration has approved Abecma (idecabtagene vicleucel; ide-cel; Bristol Myers Squibb and bluebird bio, Inc) as the first B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy for the treatment of adult patients with relapsed or refractory multiple myeloma after ≥4 prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody, according to a press release.

Approval was based on data from the pivotal Phase II KarMMa trial of 127 patients with relapsed or refractory multiple myeloma who had received ≥3 prior lines of therapy. The efficacy evaluable population included 100 patients who received a doss of Abecma within the range of 300 to 460 x 106 CAR-positive T cells.  The overall response rate for this population was 72%. A stringent complete response was achieved in 28% of patients.

“CAR T cell therapies have shown transformational potential for the treatment of hematologic malignancies, and we, with our partners at bluebird bio, are proud to bring the first CAR T cell therapy to appropriate triple-class exposed patients with relapsed or refractory multiple myeloma, offering the chance for durable response,” said Samit Hirawat, MD, chief medical officer, Bristol Myers Squibb, in the press release. “Bristol Myers Squibb is now the only company with two approved CAR T cell therapies with distinct targets of CD19 and BCMA. As our second FDA-approved CAR T cell therapy, Abecma underscores our commitment to deliver on the promise of cell therapies for patients who are battling aggressive and advanced blood cancers with limited effective treatment options.”

Read the full press release here.