FDA accepts Bristol Myers NDA for mezigdomide in multiple myeloma, sets May 13, 2027 decision date

Bristol-Myers Squibb Company

Bristol-Myers Squibb Company

BMY

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  • Bristol Myers Squibb secured FDA acceptance of its NDA for mezigdomide with carfilzomib, dexamethasone in relapsed or refractory multiple myeloma.
  • The FDA set a PDUFA target action date of May 13, 2027.
  • Filing backed by Phase 3 SUCCESSOR-2 data showing median PFS 18.0 months vs. 8.3 months; HR 0.48; p<0.0001.


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