BMS：Mezigdomide has been formally accepted for review.
On June 16, the CDE official website showed that the New Drug Application (NDA) for Mezigdomide capsules, developed by BMS, has been accepted. The drug is indicated for use in combination with carfilzomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have previously received lenalidomide and an anti-CD38 monoclonal antibody. This indication has previously been granted Priority Review and Breakthrough Therapy designation.
Mezigdomide is a novel, specifically optimized CELMoD (cereblon E3 ligase modulator) drug with enhanced myeloma cell killing and immune activation capabilities compared with traditional immunomodulatory (IMiD) agents. The product is currently being investigated in clinical studies for multiple myeloma and acute myeloid leukemia indications.
In March 2026, BMS announced positive results from an interim analysis of the first Phase III SUCCESSOR-2 study of mezigdomide. The study was designed to evaluate the efficacy and safety of mezigdomide in combination with carfilzomib and dexamethasone (MeziKd) versus carfilzomib and dexamethasone (Kd) in patients with relapsed or refractory multiple myeloma (RRMM). The results showed that oral mezigdomide in combination with carfilzomib and dexamethasone demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared with carfilzomib and dexamethasone alone in patients with RRMM.
The safety profile was manageable and predictable, with mortality rates of 21.5% in the MeziKd arm and 26.7% in the Kd arm, with the primary cause of death being disease progression.
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