Sonrotoclax Approved as a New Targeted Therapy for Mantle Cell Lymphoma
The BCL-2 inhibitor received accelerated approval for patients with relapsed or refractory mantle cell lymphoma.
The U.S. Food and Drug Administration (FDA) has granted accelerated approval to sonrotoclax (Beqalzi) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have previously received at least two lines of systemic therapy, including a Bruton tyrosine kinase (BTK) inhibitor.
Sonrotoclax is a next-generation inhibitor of the BCL-2 protein, which promotes cell survival by preventing apoptosis (programmed cell death) and is highly expressed in MCL cells. By blocking the function of this protein, sonrotoclax triggers cancer cell death. This is the first approval of a BCL-2 inhibitor for MCL.
The approval was based on the results of the single-arm, multicenter trial BGB-11417-201, which was conducted in 103 adult patients with MCL whose disease relapsed after or was refractory to anti-CD20 therapy and a BTK inhibitor.
Overall response rate was 52%, and the median time from the initiation of therapy until tumor response was 1.9 months. At an estimated median follow-up of 11.9 months, the median duration of response was 15.8 months.
The recommended dose of sonrotoclax is 320 mg taken orally once daily until disease progression or unacceptable toxicity. The regimen must begin with a four-week ramp-up period to reduce the risk of tumor lysis syndrome, a potentially life-threatening condition that occurs when toxic intracellular substances are released into the bloodstream due to the rapid death of a large number of cancer cells.
MCL is a rare and aggressive type of non-Hodgkin lymphoma that arises from B cells located in the mantle zone around the germinal centers, which are structures within the lymph node where B cells mature. According to federal statistics, it is estimated that 79,320 individuals would be diagnosed with non-Hodgkin lymphoma and 19,970 patients would die of the disease in the United States in 2026. MCL represents approximately 3% to 10% of non-Hodgkin lymphomas and has poor prognosis.
The FDA rendered its decision on May 13, 2026. Accelerated approval means that continued approval may be contingent upon a confirmatory trial. Please check this FDA web page for information about any accelerated approvals in oncology that may have been subsequently withdrawn and are no longer FDA-approved. Check this resource for updated information on all therapeutics regulated by the FDA.