BeOne Medicines has received the world’s first regulatory approval for sonrotoclax, a next-generation BCL2 inhibitor, for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL) and R/R chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL). The approval was granted in China, marking a major milestone in the global development of the therapy for B-cell malignancies.
Sonrotoclax is positioned as a foundational oncology medicine, with approval supported by clinical data demonstrating deep and durable responses along with a manageable safety profile. The regulatory decision was based on parallel submissions from two clinical studies, the results of which were presented at the 67th American Society of Hematology (ASH) Annual Meeting.
In a Phase 1/2 single-arm study involving patients with R/R MCL treated with 320 mg of sonrotoclax (n=103), the overall response rate assessed by an independent review committee was 52.4%. In a separate Phase 2 open-label study in patients with R/R CLL/SLL (n=100), the overall response rate reached 77%. Across both studies, sonrotoclax monotherapy was generally well tolerated, with adverse events considered manageable.
The approval in China forms part of BeOne Medicines’ broader global strategy to expand access to sonrotoclax. In the United States, data from the Phase 1/2 MCL study are currently under Priority Review by the US Food and Drug Administration for potential accelerated approval. The therapy has also received multiple regulatory designations from the FDA, including Breakthrough Therapy Designation for R/R MCL, Fast Track Designation for MCL and Waldenström macroglobulinemia, and Orphan Drug Designation across several hematologic malignancies.
Sonrotoclax (BGB-11417) is a highly potent and selective BCL2 inhibitor with a distinctive pharmacokinetic and pharmacodynamic profile, including a short half-life and no drug accumulation. It is being developed both as a monotherapy and in combination regimens, including with BRUKINSA, and has shown promising activity across a range of B-cell cancers. To date, more than 2,200 patients have been enrolled in the global sonrotoclax development programme.
BeOne Medicines, headquartered in Switzerland, continues to advance its oncology pipeline across hematologic and solid tumors, with a focus on improving global access to innovative cancer therapies.
