Business Wire·Jul 13, 2026, 6:59 AM ET

U.S. Food and Drug Administration Accepts Bristol Myers Squibb's New Drug Application for Mezigdomide in Patients with Relapsed or Refractory Multiple Myeloma

Bristol Myers Squibb announced the FDA acceptance of a New Drug Application for mezigdomide combined with carfilzomib & dexamethasone (MeziKd) for relapsed or refractory multiple myeloma.
The FDA assigned a target action date (PDUFA) of May 13, 2027 for this indication.
The filing is based on positive Phase 3 SUCCESSOR-2 trial results showing MeziKd significantly improved progression-free survival compared to standard of care (18.0 months vs. 8.3 months).
MeziKd demonstrated a 52% reduction in the risk of disease progression or death (HR: 0.48; p<0.0001) versus the control arm.
The trial included 479 patients, with 92.1% triple-class-exposed & 85.8% refractory to anti-CD38 antibodies.
Mezigdomide is an oral CELMoD designed to degrade Ikaros & Aiolos proteins to enhance multiple myeloma cell killing & immune stimulation.
Results were presented at the 2026 ASCO Annual Meeting & published in The Lancet.
Mezigdomide is also being evaluated in the ongoing Phase 3 SUCCESSOR-1 trial.