BMS/Bluebird BLA for Multiple Myeloma

FDA has accepted a Bristol Myers Squibb and Bluebird Bio BLA for idecabtagene vicleucel, a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy for treating adult patients with multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.

The companies say the submission is based on results from the pivotal Phase 2 KarMMa study. Data indicated that the study met its primary endpoint of overall response rate, and the key secondary endpoint of complete response rate in the patient population treated with the therapy, they say.

BCMA is a protein that is nearly universally expressed on cancer cells in multiple myeloma, according to the companies. It is the first CAR T cell therapy submitted for regulatory approval to target the antigen and for multiple myeloma.