BMS: Mezigdomide capsule included in priority review
On June 2, the CDE official website announced that BMS’s Mezigdomide capsules have been formally included in the priority review process, which is expected to accelerate its approval and market launch in China. The drug is intended for the treatment of adult patients with relapsed/refractory multiple myeloma, offering a next-generation therapeutic option in clinical practice.
Multiple myeloma is a hematologic malignancy that remains difficult to cure in clinical practice, with high relapse rates and significant treatment challenges. Most patients still experience disease recurrence after achieving remission through multiple lines of therapy. As the number of treatment lines increases, patients show progressively lower response rates to subsequent regimens and continuously shorter durations of remission. This represents a common clinical pain point in the current myeloma treatment landscape.
At the 2026 ASCO Annual Meeting, BMS announced positive preliminary results from the pivotal Phase III SUCCESSOR-2 (NCT05552976) study of Mezigdomide. The study conducts a head-to-head comparison of the efficacy and safety of the MeziKd regimen versus the classic Kd regimen in patients with relapsed/refractory multiple myeloma.
The key clinical data show clear advantages for the combination therapy: the median progression-free survival in the MeziKd arm reaches 18.0 months, significantly higher than 8.3 months in the control arm; the overall response rate is 80.2%, compared to 53.4% in the control arm; the rate of deep response (complete response or better) is 26.7%, far exceeding the 8.9% in the control arm. The overall efficacy demonstrates a marked improvement.
In terms of product pipeline strategy, Mezigdomide represents BMS’s next-generation core asset designed to succeed Revlimid and Pomalyst, two drugs that have long supported BMS’s market position in multiple myeloma. However, with patent expirations, Pomalyst is already facing generic competition. In March this year, its generic version officially entered the U.S. market, and as a result, BMS’s first-quarter Pomalyst sales decline by 22% year-over-year, creating an urgent need for pipeline renewal. Mezigdomide’s positive Phase III data and its priority review progress in China precisely fill this market gap left by the older drugs.
Beyond Mezigdomide, BMS is simultaneously advancing another next-generation oral myeloma drug, Iberdomide, which has already submitted a New Drug Application to the FDA, with a PDUFA target action date of August 17, 2026. Both new drugs belong to the CELMoDs (CRBN E3 ligase modulators) class, 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.
Overall, BMS leverages its next-generation CELMoDs drug matrix, with superior clinical potential and dosing flexibility, to continuously consolidate its pipeline advantage in the oral multiple myeloma treatment space, completing the iterative upgrade from traditional immunomodulatory drugs to newer agents.
