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US FDA Delay For Abecma In Early MM Gives Carvykti Time To Catch Up

 
• By Jessica Merrill

Bristol Myers and 2seventy bio are hoping Abecma will be the first CAR-T therapy for earlier lines of multiple myeloma, but an advisory committee meeting will hold up the sBLA.

delayed sign
• Source: Shutterstock

The US Food and Drug Administration will hold an Oncologic Drugs Advisory Committee (ODAC) meeting to review Bristol Myers Squibb Company and 2seventy Bio, Inc.’s supplemental biologics license application (sBLA) for the CAR-T therapy Abecma (idecabtagene vicleucel) for earlier lines of multiple myeloma, meaning it will miss the the 16 December FDA action date.

Key Takeaways
  • The FDA plans to convene an advisory committee to review approval of Abecma in earlier lines of multiple myeloma therapy, and will miss the original user fee deadline.

The companies announced the update on 20 November and said an advisory committee meeting date has not been set. The...

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