The U.S. Food and Drug Administration (FDA) on Monday accepted the new drug application for Bristol Myers Squibb & Co.’s (NYSE:BMY) investigational oral therapy mezigdomide in combination with carfilzomib and dexamethasone for relapsed or refractory multiple myeloma.
The agency assigned a Prescription Drug User Fee Act target action date of May 13, 2027, with the filing supported by positive Phase 3 SUCCESSOR-2 trial results.
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FDA Accepts Mezigdomide Application
Mezigdomide is an oral cereblon E3 ligase modulator (CELMoD), being developed to treat multiple myeloma.
The NDA seeks approval of the combination regimen, known as MeziKd, for patients with relapsed or refractory disease.
He noted Bristol Myers Squibb now has two separate agents under FDA review for relapsed or refractory multiple myeloma, adding that the company continues to advance its CELMoD pipeline across blood cancers and solid tumors.
Phase 3 SUCCESSOR-2 Trial Results
The NDA is based on data from the Phase 3 SUCCESSOR-2 study, which evaluated MeziKd against the standard regimen of carfilzomib and dexamethasone (Kd).
According to the company, the combination delivered a clinically meaningful and statistically significant improvement in progression-free survival.
Median progression-free survival reached 18.0 months compared with 8.3 months for the control arm, translating to a 52% reduction in the risk of disease progression or death (HR: 0.48).
The benefit was observed in patients with relapsed or refractory multiple myeloma, including those receiving treatment after a prior anti-CD38 monoclonal antibody and lenalidomide.
Safety Profile and Next Steps
Bristol Myers Squibb said the safety profile of MeziKd was consistent with findings from previous mezigdomide studies and aligned with the known safety profiles of the individual medicines included in the regimen.
The company also acknowledged the patients and investigators who participated in the Phase 3 SUCCESSOR-2 trial.
BMY Stock Price Activity: Bristol-Myers Squibb shares were up 2.29% at $58.90 at the time of publication on Monday, according to Benzinga Pro data.
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