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A group of independent advisors to the FDA voted on Friday in support of expanding the current labeling for Abecma, a CAR-T cell therapy developed by Bristol Myers Squibb (NYSE:BMY) and 2seventy bio (NASDAQ:TSVT), a decision that could lead to a better market opportunity for the multiple myeloma therapy.
The FDA’s independent advisors on cancer drugs voted 8 to 3 in favor of Abecma’s benefit-risk profile, Bristol Myers (BMY) and 2seventy bio (TSVT) announced late Friday.
Their endorsement relates to the companies’ supplemental biologics license application for Abecma, which is currently under FDA review for approval in an earlier line setting in multiple myeloma.
The BCMA-targeting CAR T cell immunotherapy is currently approved in the U.S. for adults with multiple myeloma who have received four or more prior lines of therapy.
The FDA is not bound by the decisions of its advisory committees. However, the regulator usually considers their views before finalizing drug approvals.
The voting on Abecma comes after Johnson & Johnson (JNJ) and Legend Biotech (LEGN) won unanimous AdCom backing for a similar label expansion for their CAR-T therapy Carvykti on Friday.
