FDA extends review of Bristol Myers Squibb's filing for CAR T-cell therapy lisocabtagene maraleucel

Bristol Myers Squibb said Wednesday that the FDA has extended its review of a marketing application seeking approval of lisocabtagene maraleucel (liso-cel) for the treatment of adults with relapsed or refractory large B-cell lymphoma after at least two prior therapies, with a decision on the filing now expected by November 16. The company gained the CD19-directed CAR T-cell therapy via its $74-billion buyout of Celgene last November, with US approval of liso-cel by the end of 2020 being one of the conditions tied to contingent value rights (CVR) issued as part of the takeover.

Bristol Myers Squibb explained that since its liso-cel filing was accepted for review in February, the company has submitted additional information to the FDA, which was "deemed to constitute a major amendment" to the application and will require more time for review.

The CVR will permit holders to receive a cash payment of $9 upon FDA approval of three therapies. One of the treatments, the S1P receptor modulator Zeposia (ozanimod), was cleared by the agency in March for adults with relapsing forms of multiple sclerosis (for related analysis, see ViewPoints: Zeposia eases regulatory anxiety).

Aside from liso-cel, the other remaining milestone of the CVR is US approval of idecabtagene vicleucel (ide-cel) by the end of March 2021. Earlier this year, Bristol Myers Squibb and partner bluebird bio filed ide-cel for FDA approval to treat certain adults with multiple myeloma who have received at least three prior therapies. Ide-cel, also known as bb2121, is a BCMA-directed CAR T-cell immunotherapy.

Bristol Myers Squibb said it "is committed to working with FDA to progress both applications and achieve the remaining regulatory milestones required by the CVR."

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