FDA Accepts New Drug Application for Mezigdomide Combination in Relapsed or Refractory Multiple Myeloma
Clinical Summary:
- The FDA accepted Bristol Myers Squibb's new drug application for mezigdomide, an investigational oral cereblon E3 ligase modulator (CELMoD), in combination with carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma based on findings from the phase 3 SUCCESSOR-2 trial.
- In the phase 3 SUCCESSOR-2 trial, mezigdomide plus carfilzomib and dexamethasone significantly improved progression-free survival compared with carfilzomib and dexamethasone alone while demonstrating a safety profile consistent with previous studies of mezigdomide and the individual agents.
- If approved, mezigdomide could provide a new treatment option for patients with relapsed or refractory multiple myeloma, including those with disease progression following prior anti-CD38 monoclonal antibody and lenalidomide therapy.
The US Food and Drug Administration (FDA) has accepted the new drug application for mezigdomide (Bristol Myers Squibb) in combination with carfilzomib and dexamethasone for patients with relapsed or refractory multiple myeloma, supporting the investigational oral cereblon E3 ligase modulator as a potential new treatment option.
This acceptance is supported by findings from the phase 3 SUCCESSOR-2 trial. In this multicenter, open-label trial, 479 patients with relapsed or refractory multiple myeloma were randomized to receive either mezigdomide in combination with carfilzomib and dexamethasone (n = 288) or carfilzomib and dexamethasone alone (n = 191). The primary end point was progression-free survival (PFS).
At analysis, mezigdomide plus carfilzomib and dexamethasone reduced the risk of disease progression or death by 52% compared with carfilzomib and dexamethasone alone (hazard ratio [HR], 0.48; P < .0001). Median PFS was 18 months with the mezigdomide combination and 8.3 months in the control arm.
The safety profile of mezigdomide was consistent with prior findings and with the known safety profiles of the individual agents in the regimen. Results from SUCCESSOR-2 were presented during a late-breaking oral session at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in The Lancet.
“We're rapidly progressing the development of our CELMoD pipeline and are committed to leveraging this platform to bring the next wave of advances for patients in both hematologic malignancies and solid tumors,” stated Cristian Massacesi, MD, executive vice president, chief medical officer, and head of development at Bristol Myers Squibb.
The agency assigned a Prescription Drug User Fee Act (PDUFA) target action date of May 13, 2027.
Source:
Bristol Myers Squibb. US Food and Drug Administration accepts Bristol Myers Squibb's new drug application for mezigdomide in patients with relapsed or refractory multiple myeloma. Accessed July 13, 2026. https://news.bms.com/news/corporate-financial/2026/U-S--Food-and-Drug-Administration-Accepts-Bristol-Myers-Squibbs-New-Drug-Application-for-Mezigdomide-in-Patients-with-Relapsed-or-Refractory-Multiple-Myeloma
