Bristol Myers files mezigdomide myeloma application

• Bristol Myers Squibb submitted an FDA application for mezigdomide with carfilzomib and dexamethasone in relapsed multiple myeloma.
• The FDA accepted the New Drug Application and set a PDUFA action date of May 13, 2027.
• The filing was supported by Phase 3 data showing improved progression-free survival in the SUCCESSOR-2 trial.

Bristol Myers Squibb (NYSE:BMY) announced that the U.S. Food and Drug Administration accepted its New Drug Application for mezigdomide in combination with carfilzomib and dexamethasone, known as MeziKd, for patients with relapsed or refractory multiple myeloma.

The FDA acceptance follows results from the Phase 3 SUCCESSOR-2 trial, which showed MeziKd improved progression-free survival compared with carfilzomib and dexamethasone alone in patients with previously treated multiple myeloma.

The SUCCESSOR-2 trial showed median progression-free survival of 18 months for MeziKd compared with 8.3 months for the comparison treatment, representing a 52% reduction in the risk of disease progression or death.

Bristol Myers Squibb said the FDA assigned a Prescription Drug User Fee Act action date of May 13, 2027.

Mezigdomide is an oral cereblon E3 ligase modulator (CELMoD) designed to target proteins involved in cancer cell survival and is being evaluated in multiple myeloma and other cancers.