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The FDA has granted accelerated approval to sonrotoclax (Beqalzi, BeOne Medicines), for the treatment of certain adults with relapsed or refractory mantle cell lymphoma (MCL).

Specifically, the next-generation BCL-2 inhibitor is approved for those who have received two prior lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor, according to the FDA notice. 

“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 US mantle cell lymphoma community, offering renewed hope for patients and families who have exhausted other available therapies,” Meghan Gutierrez, CEO of the Lymphoma Research Foundation stated in a press release.

Approval was based on findings from the phase 1/2 single-arm, multicenter BGB-11417-201 study showing an overall response rate of 52% and median duration of response of 15.8 months in 103 patients followed for an estimated median of 11.9 months. The median time to response was 1.9 months.

Findings from the study were reported in December 2025 at the American Society of Hematology annual meeting.

Serious adverse reactions occurred in 37% of 115 patients with MCL who were evaluated for safety. The most common of these was pneumonia, occurring in 10% of patients. 

Prescribing information, which will be posted on Drugs@FDA, includes warnings and precautions for tumor lysis syndrome, serious infections, and neutropenia.

“The data supporting the approval of sonrotoclax in the US 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,” global principle investigator Michael Wang, MD, of the University of Texas MD Anderson Cancer Center, Houston, stated in the company press release. “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 recommended sonrotoclax regimen involves a 4-week ramp-up phase to reduce the risk of tumor lysis syndrome, followed by a 320-mg daily oral dose taken until disease progression or unacceptable toxicity.

Continued approval is contingent upon confirmation of clinical benefit in the ongoing confirmatory CELESTIAL-RRMCL trial.

Sharon Worcester, MA, is an award-winning medical journalist based in Birmingham, Alabama, writing for Medscape, MDedge, and other affiliate sites. She currently covers oncology, but she has also written on a variety of other medical specialties and healthcare topics. She can be reached at sworcester@mdedge.com or on X: @SW_MedReporter.