Bristol Myers Squibb Myeloma Drug Enters FDA Review, Cuts Progression Risk 52%

The U.S. Food and Drug Administration (FDA) accepted Bristol Myers Squibb’s New Drug Application for mezigdomide. This oral treatment targets patients with relapsed or refractory multiple myeloma.

The application seeks approval for mezigdomide in combination with carfilzomib and dexamethasone. Data from the Phase 3 SUCCESSOR-2 trial supports the submission.

The mezigdomide combination demonstrated a 52% reduction in the risk of disease progression or death. This result represents a statistically significant improvement over the current standard of care.

Mezigdomide functions as a cereblon E3 ligase modulator (CELMoD). The FDA set a Prescription Drug User Fee Act (PDUFA) target action date of May 13, 2027.