FDA
Beqalzi becomes first BCL2 inhibitor to be FDA-approved for mantle cell lymphoma
Relapsed or refractory mantle cell lymphoma (MCL) remains difficult to treat after progression on Bruton tyrosine kinase (BTK) inhibitors, with limited effective therapies available and generally poor outcomes. FDA has now approved the first BCL2 inhibitor specifically for MCL, introducing a new targeted treatment option in this setting.
On May 13, 2026, FDA granted accelerated approval to Beqalzi (sonrotoclax) for adults with relapsed or refractory mantle cell lymphoma after at least two prior lines of systemic therapy, including a BTK inhibitor. This marks the first U.S. approval of sonrotoclax, a next-generation BCL2 inhibitor designed with greater potency and selectivity than earlier agents in the class.
The approval was supported by results from the phase 1/2 BGB-11417-201 trial. Among treated patients, overall response rate was 52% (95% confidence interval, 42%-62%), with a complete response rate of 16%. Median time to response was 1.9 months, and median duration of response was 15.8 months at a median follow-up of 11.9 months.
Continued approval is contingent on confirmation of clinical benefit in the ongoing phase 3 CELESTIAL-RRMCL trial.
The prescribing information includes warnings for tumor lysis syndrome, serious infections, neutropenia, and embryo-fetal toxicity. Laboratory or clinical tumor lysis syndrome occurred in 7% of patients who followed the recommended dose ramp-up schedule. The most common adverse effects were pneumonia and fatigue.
“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,” said Michael Wang, MD, professor in the Department of Lymphoma and Myeloma at The University of Texas MD Anderson Cancer Center and global principal investigator of the study.
Source: BeOne Medicines Ltd. (2026, May 13). Press release. BeOne Medicines’ Beqalzi (sonrotoclax) approved by U.S. FDA as first and only BCL2 inhibitor for relapsed/refractory mantle cell lymphoma