USFDAMay 15, 2026, 04:19 PM
BeOne Medicines' BEQALZI Receives US FDA Accelerated Approval
AI Summary
BeOne Medicines Ltd. announced that its drug BEQALZI (sonrotoclax) received accelerated approval from the U.S. FDA for treating adult patients with relapsed or refractory mantle cell lymphoma (R/R MCL) after at least two lines of systemic therapy, including a BTK inhibitor. This marks the first and only BCL2 inhibitor approved for MCL in the U.S., aiming to set a new standard of care. The approval is supported by Phase 1/2 study data showing a 52% overall response rate and a 16% complete response rate.
Key Highlights
- BeOne Medicines' BEQALZI (sonrotoclax) received US FDA accelerated approval for relapsed or refractory mantle cell lymphoma (R/R MCL).
- BEQALZI is the first and only BCL2 inhibitor approved for R/R MCL in the U.S.
- Phase 1/2 study data showed an Overall Response Rate (ORR) of 52% and a Complete Response (CR) rate of 16%.
- The median Duration of Response (DOR) observed was 15.8 months.
- The drug was granted Breakthrough Therapy, Fast Track, and Orphan Drug Designations.
- BEQALZI is also approved in China for R/R MCL and chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).
- Over 2,200 patients have been enrolled across the global sonrotoclax development program.
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