Bristol Myers Squibb/2seventy bio’s Abecma approved for triple-class exposed multiple myeloma patients after two prior lines of therapy on 4 April 2024, moving use of the CAR-T therapy earlier than its original fifth-line-plus indication.
FDA’s inclusion of data on early deaths in the pivotal trial in the warnings and precautions section of labeling (but not the boxed warning) suggests that the agency’s concerns were assuaged by a March advisory committee meeting.
Abecmas’ expanded indication would seem to bode well for Carvykti’s sBLA, but the J&J CAR-T therapy’s 5 April goal date came to a close with no announcement of an FDA action from the company or the agency.

Abecma Approval In Earlier Myeloma Carries Caution On Early Death Data

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