Bristol Myers Squibb said the FDA has accepted its New Drug Application for mezigdomide in combination with carfilzomib and dexamethasone (MeziKd) for adults with relapsed or refractory multiple myeloma. The agency has set a Prescription Drug User Fee Act (PDUFA) target action date of May 13, 2027.
Mezigdomide is an oral cereblon E3 ligase modulator (CELMoD) designed to enhance targeted protein degradation in multiple myeloma. The filing is supported by results from the Phase 3 SUCCESSOR‑2 trial, which evaluated MeziKd versus carfilzomib and dexamethasone alone in patients whose disease had relapsed or was refractory, including those at first relapse after treatment with an anti‑CD38 monoclonal antibody and lenalidomide.
In SUCCESSOR‑2, MeziKd significantly improved progression‑free survival, with median PFS of 18.0 months versus 8.3 months for the control regimen, corresponding to a 52% reduction in the risk of disease progression or death (hazard ratio 0.48; p<0.0001). The safety profile of the triplet regimen was consistent with prior studies of mezigdomide and with the known safety characteristics of carfilzomib and dexamethasone.
Multiple myeloma remains a chronic, relapsing hematologic malignancy in which patients typically cycle through several lines of therapy over time. Bristol Myers Squibb noted that mezigdomide is part of a broader CELMoD pipeline the company is advancing in hematologic cancers and solid tumors, with another agent already under regulatory review in relapsed or refractory myeloma.
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