BeOne Medicines, a global oncology leader, has announced a landmark first-in-world approval of sonrotoclax, its next-generation BCL2 inhibitor, for adult patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL) and R/R chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) in China.

 

The approval is backed by data showing deep, durable responses and manageable tolerability, highlighting sonrotoclax’s potential as a foundational therapy across B-cell malignancies.

 

“The approval of sonrotoclax marks a major milestone for patients with relapsed or refractory MCL and CLL/SLL,” the company said.

 

The decision follows submissions of data from two pivotal studies presented at the 67th American Society of Hematology (ASH) Annual Meeting in Orlando, Florida.

 

In a Phase 1/2 single-arm study of 103 patients with R/R MCL treated with 320 mg of sonrotoclax, the overall response rate (ORR) was 52.4% as assessed by an independent review committee (IRC). In a Phase 2 study of 100 patients with R/R CLL/SLL, sonrotoclax achieved a 77% ORR by IRC assessment. Across both trials, sonrotoclax monotherapy was generally well tolerated, with adverse events manageable.

 

“The approval in China is part of our global strategy to advance access to sonrotoclax,” the company added. Data from the Phase 1/2 MCL study are currently under Priority Review by the US FDA for potential accelerated approval.