BeiGene just announced that BEQALZI ™ (Sotopra ) has received accelerated approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory ( R/R ) mantle cell lymphoma ( MCL ) who have received at least two lines of prior systemic therapy, including a Bruton's tyrosine kinase [ BTK] inhibitor .
Sotopra is a next-generation BCL2 inhibitor with cornerstone potential in BCL2 target development . Its development and design aim to enhance the effect of BCL2 inhibitors, and it has been optimized in terms of molecular efficacy and selectivity. Its pharmacological properties are also expected to improve the efficacy, tolerability and convenience of medication.
This accelerated approval of Sotopra is based on efficacy and safety data from the Phase 1/2 study BGB-11417-201 ( NCT05471843 ) , the results of which were presented at the 67th Annual Meeting of the American Society of Hematology ( ASH ). The independently reviewed efficacy data are as follows:
o Overall response rate ( ORR ): 52% ( 95% CI: 42-62 )
o Complete remission ( CR ) rate: 16% ( 95% CI: 9.1-24.0 )
o Median time to response ( TTR ): 1.9 months
o Median duration of response ( DOR ): 15.8 months ( 95% CI : 7.4 months to NE ), median follow-up time: 11.9 months (data not yet fully mature).
o Safety: Sotopra monotherapy was generally well tolerated.
The continued approval of this indication depends on whether the ongoing CELESTIAL-RRMCL confirmatory trial ( NCT06742996 ) can demonstrate its clinical benefit. The FDA has granted Sotopra Breakthrough Therapy Designation ( BTD ), as well as Fast Track Designation and Orphan Drug Designation for this indication .
Sotopra has also been approved in China for the treatment of relapsed/relapsed MCL and adult patients with chronic lymphocytic leukemia ( CLL ) / small lymphocytic lymphoma ( SLL ) who have previously received at least one systemic therapy including a BTK inhibitor. The European Medicines Agency ( EMA ) and other drug regulatory agencies are currently reviewing Phase 1/2 study data on sotopra for the treatment of relapsed/relapsed MCL .
The U.S. FDA also granted Sotopra Fast Track designation for the treatment of Waldenström macroglobulinemia ( WM ), and Orphan Drug designation for the treatment of adult patients with WM , multiple myeloma, acute myeloid leukemia, and myelodysplastic syndrome.
In addition, BeiGene is currently exploring the potential of sotopra as a combination therapy with other drugs (including zanubrutinib) for the treatment of CLL . The latest data from related studies are expected to be presented at the American Society of Clinical Oncology ( ASCO ) Annual Meeting in 2026 .

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