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The FDA on May 13, 2026 granted accelerated approval to Beqalzi (sonrotoclax), BeOne Medicines' once-daily tablet, for adults with relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy, including a Bruton's tyrosine kinase inhibitor.
Sonrotoclax inhibits BCL-2, a protein that helps cancer cells survive when it is overexpressed. The drug binds BCL-2 and displaces the pro-apoptotic proteins it holds, which sets off cell death. BeOne describes Beqalzi as the first and only BCL-2 inhibitor approved in the US for relapsed or refractory mantle cell lymphoma.
Approval rests on BGB-11417-201 (NCT05471843), a single-arm trial in 103 adults who had already received anti-CD20 therapy and a BTK inhibitor, with a median of three prior lines of treatment. After a four-week dose ramp-up, patients took 320 mg once daily. An independent review committee found an overall response rate of 52%, with complete responses in 16% and a median duration of response of 15.8 months. Median time to response was 1.9 months.
The label warns of tumor lysis syndrome, which occurred in 7% of patients who followed the ramp-up, along with serious infections and neutropenia.
Continued approval may depend on a confirmatory trial. The study had no comparator arm, and clinical benefit has yet to be confirmed in the labeled population.
Sources: FDA prescribing information; Drugs@FDA, NDA 220711; FDA approval notice; BeOne Medicines press release; BGB-11417-201 (NCT05471843)
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