Bristol Myers Squibb’s New Drug Application (NDA) for mezigdomide has been accepted by the US FDA. Mezigdomide is an oral cereblon E3 ligase modulator, or CELMoD, that leads to higher multiple myeloma cell killing and immune stimulation than traditional immunomodulatory agents.
The application is based on results from the phase 3 SUCCESSOR-2 trial showing oral CELMoD mezigdomide, in combination with carfilzomib and dexamethasone (MeziKd), significantly improves progression-free survival in patients with relapsed or refractory multiple myeloma (RRMM) vs standard of care.
The phase 3 trial of MeziKd showed a 52% reduction in the risk of disease progression or death compared with Kd in patients with RRMM, including those at first relapse after prior treatment with an anti-CD38 monoclonal antibody and lenalidomide.
Pre-clinical data suggests the drug enhances T-cell function and reinvigorates patients’ exhausted immune systems. It is also being evaluated in the ongoing phase 3 SUCCESSOR-1 trial vs. standard of care regimen in relapsed or refractory multiple myeloma.
“The FDA’s acceptance of our application for mezigdomide highlights the continued momentum of our targeted protein degradation programmes, as we now have two distinct agents under review in relapsed or refractory multiple myeloma, which remains a persistent disease,” said Cristian Massacesi, executive vice president, chief medical officer and head of development, Bristol Myers Squibb. “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 tumours.”
Results were recently presented at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting as a late-breaking oral presentation and published in The Lancet. The US FDA has assigned a target action date of 13 May 2027 for this New Drug Application.