FDA accepts new drug application for mezigdomide combination based on SUCCESSOR-2 trial results; Prescription Drug User Fee Act target action date set for May 13, 2027
 

On Monday, July 13, the U.S. Food and Drug Administration (FDA) accepted Bristol Myers Squibb's (BMS) New Drug Application (NDA) for mezigdomide in combination with carfilzomib and dexamethasone (MeziKd) to treat adults with relapsed or refractory multiple myeloma (RRMM).

Mezigdomide is an investigational oral cereblon E3 ligase modulator (CELMoD) designed to promote degradation of the Ikaros and Aiolos proteins, increasing multiple myeloma cell death and stimulating immune activity.

The FDA has set May 13, 2027, as the Prescription Drug User Fee Act (PDUFA) target action date for the MeziKd NDA.

According to a press release from BMS, the application is supported by results from the Phase III SUCCESSOR-2 trial, which showed that MeziKd significantly improved progression-free survival (PFS) compared with carfilzomib and dexamethasone (Kd) alone. Median PFS was 18.0 months with MeziKd versus 8.3 months with Kd (hazard ratio 0.48; p<0.0001), corresponding to a 52% reduction in the risk of disease progression or death.

The benefit was observed in patients with RRMM, including those receiving treatment at first relapse after prior therapy with an anti-CD38 monoclonal antibody and lenalidomide. Investigators reported that the safety profile of the MeziKd regimen was consistent with previous studies of mezigdomide and with the known safety profiles of the individual drugs.

479 RRMM patients were enrolled in the SUCCESSOR-2 trial, with median patient age at 68 years. Participants had received a median of two prior lines of therapy. More than 92% had previously been exposed to three major classes of multiple myeloma treatments, while 85.8% were refractory to an anti-CD38 monoclonal antibody and 75.8% were refractory to lenalidomide.

The SUCCESSOR-2 trial findings were presented as a late-breaking oral presentation at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting and were also published in The Lancet.

Mezigdomide is also being evaluated in the ongoing Phase 3 SUCCESSOR-1 trial in RRMM.

References:
U.S. Food and Drug Administration Accepts Bristol Myers Squibb's New Drug Application for Mezigdomide in Patients with Relapsed or Refractory Multiple Myeloma. BMS press release. July 13, 2026.

Dimopoulos MA, Schjesvold F, Fu C, et al. Mezigdomide, carfilzomib, and dexamethasone versus carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma (SUCCESSOR-2): a phase 3, open-label, randomised controlled trial. Lancet. 2026 Jun 14:S0140-6736(26)01088-3. doi: 10.1016/S0140-6736(26)01088-3.