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Sonrotoclax, sold under the brand name Beqalzi, is a medication used for the treatment of hematologic malignancies, particularly chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).[1] It is a potent and selective BCL2 inhibitor that can overcome resistance associated with BCL2 mutations, such as the G101V variant, which limits the effectiveness of first-generation inhibitors like venetoclax.[2]
Sonrotoclax is indicated for the treatment of adults with relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy, including a Bruton's tyrosine kinase inhibitor.[3]
Sonrotoclax is contraindicated with strong CYP3A inhibitors at initiation and ramp-up phase due to potential increased risk of Tumor lysis syndrome.[3]
Sonrotoclax was approved by the FDA for medical use in the United States in May 2026.[3] Sonrotoclax is also approved in China for mantle cell lymphoma, along with CLL/SLL.[3]
Sonrotoclax also has a fast track designation by the FDA for Waldenström macroglobulinemia. It additionally has an orphan drug designation by the FDA for Waldenström macroglobulinemia, multiple myeloma, acute myeloid leukemia, and myelodysplastic syndromes.[3]
Sonrotoclax is the international nonproprietary name.[4]
Sonrotoclax is sold under the brand name Beqalzi.[3]