PRINCETON, New Jersey, July 13, 2026
Bristol Myers Squibb (BMS) has announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for mezigdomide in combination with carfilzomib and dexamethasone (MeziKd) for the treatment of patients with relapsed or refractory multiple myeloma (RRMM). The regulatory submission is supported by positive results from the pivotal Phase 3 SUCCESSOR-2 clinical trial, which demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared with the current standard-of-care regimen. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of May 13, 2027, marking an important milestone in the advancement of BMS’ targeted protein degradation pipeline. The acceptance reinforces the company’s commitment to delivering innovative treatment options for patients with relapsed multiple myeloma, an incurable blood cancer where disease progression remains common despite existing therapies.
SUCCESSOR-2 Trial Demonstrates Significant Clinical Benefit
The NDA submission is based on data from the global Phase 3 SUCCESSOR-2 trial, which evaluated mezigdomide, an oral Cereblon E3 Ligase Modulator (CELMoD), combined with carfilzomib and dexamethasone in patients with relapsed or refractory multiple myeloma. The study met its primary endpoint by demonstrating a 52% reduction in the risk of disease progression or death compared with carfilzomib and dexamethasone alone. Median progression-free survival reached 18.0 months for patients receiving the MeziKd combination versus 8.3 months for the control group, representing a substantial clinical improvement for heavily pretreated patients.
The trial enrolled 479 participants, many of whom had previously received anti-CD38 monoclonal antibodies, lenalidomide, and multiple prior treatment regimens. The safety profile of the combination remained consistent with previous clinical studies, with no unexpected safety concerns identified during the trial.
Mezigdomide Expands Targeted Protein Degradation Innovation
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Mezigdomide belongs to Bristol Myers Squibb’s next-generation CELMoD platform, a proprietary class of targeted protein degradation therapies designed to selectively eliminate disease-driving proteins by modulating the cereblon E3 ligase pathway. Unlike conventional immunomodulatory agents, mezigdomide has been specifically engineered to induce rapid degradation of the transcription factors Ikaros and Aiolos, resulting in enhanced multiple myeloma cell destruction while simultaneously stimulating immune activity.
Preclinical research has also demonstrated its ability to restore exhausted T-cell function, supporting broader immune-mediated anti-tumor responses. In addition to the SUCCESSOR-2 program, the investigational therapy continues to be evaluated in the ongoing Phase 3 SUCCESSOR-1 trial, further expanding its potential role in the treatment landscape for relapsed multiple myeloma.
Regulatory Milestone Strengthens BMS Oncology Pipeline
The FDA’s acceptance of the NDA highlights the continued momentum of Bristol Myers Squibb’s oncology and hematology portfolio, particularly its leadership in targeted protein degradation technologies. The company now has two investigational protein degrader therapies under regulatory review for relapsed or refractory multiple myeloma, reinforcing its long-term strategy of developing innovative treatments for patients with significant unmet medical needs. With the PDUFA decision expected by May 13, 2027, the regulatory review represents an important step toward potentially introducing a new oral therapeutic option capable of improving outcomes for patients whose disease has progressed following multiple prior therapies.
If approved, mezigdomide could further expand treatment choices in multiple myeloma, supporting continued advances in precision oncology and reinforcing Bristol Myers Squibb’s commitment to delivering next-generation therapies that improve survival and quality of life for patients with hematologic malignancies.
Source: Bristol Myers Squibb press release
