The US Food and Drug Administration (FDA) has granted accelerated approval to Beqalzi (sonrotoclax) for the treatment of adults with relapsed or refractory (R/R) mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor.
MCL is a rare form of malignant non-Hodgkin lymphoma affecting B lymphocytes in the lymph nodes within a region called the “mantle zone”. Early symptoms include fever, involuntary weight loss, and night sweats. Although MCL usually responds well to initial treatment, it is common for patients to relapse or become refractory.
The approval was based on safety and efficacy data from the phase 1/2 BGB-11417-201 (NCT05471843) clinical trial presented at the 2025 American Society of Hematology (ASH) Annual Meeting and Exposition. This was a single-arm, open-label, multicenter study evaluating the efficacy, safety, and pharmacokinetics of sonrotoclax in patients with R/R MCL. Sonrotoclax is a highly potent and specific B-cell lymphoma 2 (BCL2) inhibitor.
Efficacy data from the study illustrated a 52% overall response rate and a 16% complete response rate. The median time to response was 1.9 months and the median duration of response was 15.8 months at a median response follow-up of 11.9 months. In terms of safety, sonrotoclax was generally well tolerated.
Continued approval for this indication is contingent upon confirmation of clinical benefit from the CELESTIAL-RRMCL (NCT06742996) clinical trial that is currently ongoing.
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To learn more about MCL and other rare cancers, visit https://checkrare.com/diseases/cancers/
