mezigdomide (CELMoD (CC-92480)) in combination with carfilzomib and dexamethasone (MeziKd) - (SUCCESSOR-2)

July 13, 2026: Bristol Myers Squibb (NYSE: BMY) announced the FDA accepted its New Drug Application for mezigdomide (an oral CELMoD) in combination with carfilzomib and dexamethasone (MeziKd) for patients with relapsed or refractory multiple myeloma (RRMM). The FDA assigned a PDUFA target action date of May 13, 2027.

The NDA is supported by the Phase 3 SUCCESSOR-2 trial (NCT05552976), a randomized open-label study comparing MeziKd vs carfilzomib+dexamethasone (Kd). SUCCESSOR-2 met its primary endpoint, showing a statistically significant progression-free survival benefit: median PFS 18.0 months with MeziKd vs 8.3 months with Kd (HR 0.48; p<0.0001), described as a 52% reduction in risk of progression or death. The company said the MeziKd safety profile was consistent with prior mezigdomide studies and known profiles of the individual agents.

The results were presented as a late-breaking oral presentation at the 2026 ASCO Annual Meeting and published in The Lancet. Mezigdomide is also being evaluated in the ongoing Phase 3 SUCCESSOR-1 trial in RRMM.