BEQALZI wins US accelerated approval in relapsed/refractory mantle cell lymphoma

BeOne Medicines, a global oncology company, has secured accelerated approval from the US Food and Drug Administration for BEQALZI™ (sonrotoclax), a next-generation BCL2 inhibitor, for adults with relapsed or refractory (R/R) mantle cell lymphoma (MCL) who have received at least two prior lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor. The drug has been engineered to deliver greater potency and selectivity than earlier BCL2 inhibitors, with a pharmacologic profile aimed at improving efficacy, tolerability and convenience versus others in the class.

Michael Wang, M.D., Global Principal Investigator, the Puddin Clarke Endowed Professor, Department of Lymphoma and Myeloma, The University of Texas MD Anderson Cancer Center, said: “The data supporting the approval of sonrotoclax in the U.S. confirm its role as a foundational therapy for mantle cell lymphoma in the post-BTK inhibitor setting, and demonstrate that it can deliver robust disease control when treatment choices are limited and outcomes are poor. From a clinical perspective, this provides physicians with an important new option grounded in both efficacy and tolerability, fundamentally changing how we think about sequencing therapy in this disease.”

The approval is anchored in efficacy and safety data from the Phase 1/2 BGB-11417-201 study, which were presented at the 67th American Society of Hematology Annual Meeting & Exposition. Based on an independent review, sonrotoclax produced an overall response rate of 52% (95% CI 42–62) and a complete response rate of 16% (95% CI 9.1–24.0), with a median time to response of 1.9 months. Median duration of response reached 15.8 months (95% CI 7.4–NE) at a median response follow-up of 11.9 months, with the data not yet fully mature. Sonrotoclax monotherapy was generally well tolerated. Continued approval in this indication will hinge on confirmation of clinical benefit in the ongoing CELESTIAL-RRMCL confirmatory trial. The FDA had previously granted sonrotoclax Breakthrough Therapy, Fast Track and Orphan Drug Designations in this setting.

MCL is a rare and frequently aggressive subtype of non-Hodgkin lymphoma, with around 3,300 new diagnoses annually in the United States. Although many patients respond to initial therapy, relapse is common and outcomes after progression — particularly following BTK inhibitor exposure — remain poor. The approval introduces a new targeted mechanism into the MCL armamentarium at a point in the disease course where options are most constrained.

Amit Agarwal, M.D., Ph.D., Chief Medical Officer, Hematology, BeOne Medicines, said: “BeOne is leading the advancement and enhancement of BCL2 inhibition to revolutionize how we treat patients living with B-cell malignancies. Today’s approval of BEQALZI represents critical progress for patients with mantle cell lymphoma and reinforces our strategy of building foundational medicines designed to raise the standard of care in B-cell malignancies.”

Meghan Gutierrez, Chief Executive Officer, Lymphoma Research Foundation, said: “For people living with relapsed or refractory mantle cell lymphoma, each progression can bring uncertainty and questions regarding remaining treatment options. The FDA approval of sonrotoclax represents significant progress for the U.S. mantle cell lymphoma community, offering renewed hope for patients and families who have exhausted other available therapies. Advances like this underscore why continued research and innovation in this disease remain so critical.”

Beyond the US, BEQALZI is already approved in China for R/R MCL and for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have had at least one prior systemic therapy, including a BTK inhibitor. The R/R MCL data package from the Phase 1/2 study is also under review by the European Medicines Agency and several other regulators.

The FDA has additionally awarded sonrotoclax Fast Track Designation in Waldenström macroglobulinemia (WM), alongside Orphan Drug Designations in WM, multiple myeloma, acute myeloid leukemia and myelodysplastic syndrome. The molecule is being investigated in combination with other agents — including the BTK inhibitor zanubrutinib — as a potential treatment for CLL, with updated combination data expected at the 2026 ASCO Annual Meeting.

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Related Topics and Keywords

BEQALZI, lymphoma, mantle cell lymphoma, relapsed/refractory mantle cell lymphoma