Bristol-Myers Squibb Co:Mezigdomide formally included in the priority review and approval procedure.

On June 2, the official website of the CDE announced that Bristol Myers Squibb’s (BMS) Mezigdomide capsules have been formally included in the priority review and approval procedure, which is expected to accelerate its approval for marketing in China. The drug is primarily indicated for the treatment of adult patients with relapsed/refractory multiple myeloma, offering a next-generation therapeutic option for clinical practice.

At the 2026 ASCO Annual Meeting, BMS announced the initial positive results from the pivotal Phase III SUCCESSOR-2 (NCT05552976) study of Mezigdomide. This head-to-head study compared the efficacy and safety of the MeziKd regimen (Mezigdomide + Carfilzomib + Dexamethasone) versus the classic Kd regimen (Carfilzomib + Dexamethasone) in patients with relapsed/refractory multiple myeloma.

Based on the core clinical data, the combination regimen demonstrated clear advantages: the median progression-free survival (PFS) in the MeziKd group reached 18.0 months, significantly higher than 8.3 months in the control group; the overall response rate (ORR) was 80.2%, compared with 53.4% in the control group; and the rate of complete response or better (≥CR) was 26.7%, far exceeding the 8.9% in the control group, representing a marked improvement in overall efficacy.

In addition to Mezigdomide, BMS is simultaneously advancing another next-generation oral myeloma drug, Iberdomide, for which a marketing application has already been submitted to the FDA, with a target PDUFA action date of August 17, 2026. Both novel drugs belong to the class of CELMoDs (CRBN E3 Ligase Modulators), which are molecular glue drugs. Their core mechanism of action involves mediating the entry of pathogenic proteins into the cellular degradation system, thereby exerting therapeutic effects.

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