FDA Accepts Bristol Myers Squibb's NDAs for Two CELMoD Agents in Multiple Myeloma
The FDA accepted Bristol Myers Squibb’s NDAs for iberdomide and mezigdomide, two CELMoD agents for relapsed/refractory multiple myeloma. Iberdomide has Priority Review and a PDUFA date of Aug. 17, 2026; mezigdomide’s is May 13, 2027. The filings are backed by Phase 3 data, including a 52% PFS risk reduction for mezigdomide.
The U.S. Food and Drug Administration has accepted New Drug Applications for two distinct cereblon E3 ligase modulator (CELMoD) agents from Bristol Myers Squibb for the treatment of relapsed or refractory multiple myeloma: iberdomide and mezigdomide. Iberdomide has been granted Breakthrough Therapy Designation and Priority Review, with a Prescription Drug User Fee Act (PDUFA) target action date of August 17, 2026. Mezigdomide has a PDUFA date of May 13, 2027.
The filing for iberdomide is based on results from a planned analysis of minimal residual disease (MRD) negativity rates in the Phase 3 EXCALIBER-RRMM trial, which evaluated iberdomide in combination with daratumumab and dexamethasone (IberDd) compared to daratumumab, bortezomib, and dexamethasone (DVd). The study is ongoing and continues to assess progression-free survival. The FDA’s review of iberdomide is being conducted under Project Orbis, allowing concurrent review by international health authorities.
The mezigdomide application is supported by positive data from the Phase 3 SUCCESSOR-2 trial, which showed that mezigdomide in combination with carfilzomib and dexamethasone (MeziKd) significantly improved progression-free survival. The median PFS was 18.0 months for MeziKd versus 8.3 months for carfilzomib and dexamethasone alone (hazard ratio 0.48; p<0.0001), representing a 52% reduction in the risk of disease progression or death. The safety profile of MeziKd was consistent with prior studies. Results were recently presented at the 2026 ASCO Annual Meeting and published in The Lancet.
Both agents are oral CELMoDs designed to modulate cereblon for targeted degradation of Ikaros and Aiolos proteins, enhancing myeloma cell killing and immune stimulation. Bristol Myers Squibb is the only company with approved and commercialized protein degrader agents for multiple myeloma, and these investigational drugs represent the next generation of its protein degradation platform.