BEIGENE's BEQALZI™ Secures FDA Accelerated Approval as First and Only BCL2 Inhibitor for Relapsed/Refractory Mantle Cell Lymphoma in the U.S.

BEIGENE (06160) announced that on May 13, 2026 (Eastern Time), BEQALZI™ (sotoclax) 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 prior lines of systemic therapy, including a Bruton's tyrosine kinase (BTK) inhibitor. Sotoclax is a next-generation BCL2 inhibitor with foundational potential in BCL2-targeted development. Its design aims to enhance the effects of BCL2 inhibitors, with optimizations in molecular potency and selectivity. Its pharmacological profile is also expected to improve efficacy, tolerability, and convenience of use. Dr. Michael Wang, the global lead investigator and Professor of Lymphoma and Myeloma at The University of Texas MD Anderson Cancer Center, stated, "The data supporting sotoclax's approval in the U.S. demonstrate its significant therapeutic research position in MCL within the treatment context of prior BTK inhibitor therapy. This suggests its potential to achieve disease control in a patient population with limited treatment options and poor prognosis. From a clinical perspective, this provides new reference information for physicians in the relevant treatment field and offers a research basis for further exploring the balance between efficacy and tolerability, as well as our clinical rationale for sequential treatment strategies for this disease."