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BMS’s Abecma Shakes Up Myeloma With Earlier-Line Approval From FDA

 
• By Alaric DeArment

The US FDA approved Abecma for multiple myeloma after two prior lines of therapy, while the agency was also expected to imminently decide on earlier-line approval for J&J/Legend’s Carvykti.

• Source: Shutterstock

Bristol Myers Squibb Company and 2seventy Bio, Inc. stand to expand the addressable market for the BCMA-directed CAR-T cell therapy Abecma (idecabtagene vicleucel) now that the US Food and Drug Administration has approved it for third-line and later multiple myeloma.

The FDA gave the two companies supplemental approval for Abecma in multiple myeloma patients who have received at least two prior lines of treatment from three therapeutic classes – immunomodulatory...

Key Takeaways

  • The FDA approved BMS/2seventy bio’s Abecma for patients with multiple myeloma refractory to two lines of therapy, versus the original approval for fifth-line treatment.

    • ...

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