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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).

Key Takeaways

  • 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...

“A higher proportion of patients in the Abecma arm compared to the standard regimen’s arm died within the first 9 months of randomization” in the Phase III KarMMa-3 trial, the...

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More from US FDA Performance Tracker

US FDA’s June Approval Forecast: Infection Prevention, Cancer And HAE

 
• By Bridget Silverman

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EU CHMP Opinions And MAA Updates

 
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This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the EU, and updates on EU marketing authorization changes recommended by the CHMP.