On June 3, the Center for Drug Evaluation (CDE) published a notice on its website stating that Bristol-Myers Squibb's (BMS) Mezigdomide capsules are proposed for inclusion in the priority review and approval process. The proposed indication is for use in combination with carfilzomib and dexamethasone to treat adult patients with relapsed or refractory multiple myeloma (RRMM) who have previously received lenalidomide and anti-CD38 monoclonal antibody therapy. It is understood that this drug was recently granted Breakthrough Therapy designation by the CDE.
Multiple myeloma is a difficult-to-cure hematologic malignancy, and even after multiple lines of treatment and achieving remission, almost all patients eventually relapse. With each line of treatment, the patient's response rate to subsequent therapies and the duration of remission gradually decrease, which is a core challenge in the treatment of multiple myeloma. At the ASCO 2026 Annual Meeting, Bristol-Myers Squibb announced positive breakthrough results from the Phase III SUCCESSOR-2 study (NCT05552976), marking the first positive Phase III result for CELMoD.
This study evaluated the efficacy of mezigdomide in combination with carfilzomib and dexamethasone (MeziKd regimen) compared to carfilzomib and dexamethasone alone (Kd regimen) in patients with relapsed or refractory multiple myeloma. The results were impressive: the median progression-free survival (mPFS) of the MeziKd regimen reached 18 months, while that of the control group (Kd regimen) was only 8.3 months (HR=0.48, p<0.0001), meaning that the addition of mezigdomide reduced the risk of disease progression or death by 52%. However, safety also needs to be considered objectively. The incidence of grade 3-4 adverse events during treatment with the MeziKd regimen was 83.7%, higher than the 56.5% in the control group; among these, the incidence of neutropenia was 61.1% and 9.1%, respectively, and the incidence of infection was 34.0% and 15.6%, respectively. This means that while mezigdomide brings significant efficacy, it also comes with significant risks of myelosuppression and infection, requiring a careful balance of benefits and risks in clinical practice. However, its overall safety profile is consistent with the known safety characteristics of mezigdomide and the established toxicity spectrum of combination regimens, with no new unexpected safety signals emerging. Mezigdomide capsules provide a novel treatment option for these patients who have no other treatment options available, and as an oral formulation, they are easy to promote and use in various levels of healthcare settings.

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