The U.S. Food and Drug Administration granted accelerated approval to BeOne Medicines Ltd. (NASDAQ: ONC) for BEQALZI (sonrotoclax), a BCL2 inhibitor for treating adult patients with relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy, including a Bruton's tyrosine kinase inhibitor.

The approval makes BEQALZI the first BCL2 inhibitor approved for mantle cell lymphoma and the first new BCL2 inhibitor approved in the U.S. in a decade, according to the company's statement.

The approval is based on data from a Phase 1/2 study that showed an overall response rate of 52% and a complete response rate of 16%. The median time to response was 1.9 months, with a median duration of response of 15.8 months at a median follow-up of 11.9 months.

Mantle cell lymphoma is a rare subtype of non-Hodgkin lymphoma, with approximately 3,300 new cases diagnosed annually in the United States. The disease often responds to initial therapy but commonly relapses, with poor outcomes after progression, particularly following treatment with a BTK inhibitor.

The FDA granted the drug Breakthrough Therapy Designation, Fast Track Designation and Orphan Drug Designation. Continued approval is contingent upon confirmation of clinical benefit in the confirmatory CELESTIAL-RRMCL trial, which is underway.

BEQALZI is also approved in China for relapsed or refractory mantle cell lymphoma and for chronic lymphocytic leukemia/small lymphocytic lymphoma patients who previously received at least one systemic therapy, including a BTK inhibitor. Data from the study is under review by the European Medicines Agency and other regulatory agencies.

The most common adverse reactions include pneumonia and fatigue, each occurring in 16% of patients. The drug carries warnings for tumor lysis syndrome, serious infections, neutropenia, and embryo-fetal toxicity.