FDA accepts Bristol Myers’ application for multiple myeloma CAR T therapy

Under Priority Review status, the FDA accepts Bristol Myers Squibb’s (NYSE:BMY) marketing application seeking approval of B-cell maturation antigen (BCMA)-directed CAR T therapy idecabtagene vicleucel (ide-cel; bb2121) for the treatment of adult multiple myeloma patients who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.

The agency’s action date is March 27, 2021.

BMY is co-developing and co-promoting ide-cel in the U.S. with bluebird bio (NASDAQ:BLUE).

The FDA nod by March 31, 2021 is one of the two remaining milestones for the Contingent Value Rights (CVRs) associated with BMY’s takeover of Celgene. The other is FDA approval of liso-cel by year-end (the agency’s action date for this application is November 16). The CVR will pay out $9 if both are met.

https://seekingalpha.com/news/3616020-fda-accepts-bristol-myers-application-for-car-t-therapy-for-multiple-myeloma