1. Pink Sheet

Abecma Approval In Earlier Myeloma Carries Caution On Early Death Data

 
• By Bridget Silverman

Labeling describes early death imbalance that delayed approval of Bristol Myers Squibb’s CAR-T therapy for more than three months after its user fee goal, but does not add to boxed warning; J&J’s Carvykti is due for imminent US FDA action on its own early-stage myeloma bid.

BMS (Bristol) building
• Source: Shutterstock

The US FDA’s concerns over early deaths associated with BCMA-targeted chimeric antigen receptor T-cell (CAR-T) therapy are being handled by labeling changes, including a new section in the Warning and Precautions section in the labeling for a new indication approved 4 April 2024 for Bristol Myers Squibb Company/2seventy Bio, Inc.’s B-cell maturation agent (BCMA)-targeted chimeric antigen receptor T-cell (CAR-T) therapy Abecma (idecabtagene vicleucel).

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