FDA Delays Decision on Bristol Myers and 2seventy bio’s CAR-T Therapy for Multiple Myeloma

Nov 21, 2023

The FDA has postponed its decision on approving Bristol Myers Squibb and 2seventy bio’s CAR-T cell therapy for multiple myeloma in earlier treatment lines. Originally expected by December 16, the decision’s delay is due to the FDA’s plan to convene a public meeting with external experts. Currently, Abecma, the CAR-T therapy, is approved for patients who have undergone four or more prior treatments, but Bristol Myers and 2seventy bio sought approval for patients who had received two to four prior regimens.

The FDA’s emphasis on considering overall survival data, rather than just progression-free survival, is evident in its recent actions. The delay poses challenges for Abecma, as the therapy’s use has slowed with the approval of alternative multiple myeloma treatments, such as Carvykti. Moreover, Abecma’s Phase III study indicated a slightly higher death rate in the Abecma arm compared to standard care.

The delay is detrimental to 2seventy bio, which previously laid off 40% of its staff due to lower-than-expected Abecma sales. This setback caused a significant drop in the biotech company’s shares, which were already down 81% for the year.

Refenrence: https://news.bms.com/news/details/2023/Bristol-Myers-Squibb-and-2seventy-bio-Provide-Update-on-U.S.-FDA-Review-of-sBLA-for-Abecma-idecabtagene-vicleucel-in-Earlier-Lines-of-Therapy-for-Triple-Class-Exposed-Relapsed-or-Refractory-Multiple-Myeloma/default.aspx
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