FDA Grants Accelerated Approval to Sonrotoclax for Mantle Cell Lymphoma
The FDA approved a new cancer drug called sonrotoclax (Beqalzi) on May 13, 2026, for treating advanced mantle cell lymphoma in patients who have already tried other therapies. The drug showed a 52% response rate with a median response time of about 2 months in clinical trials.
New Lymphoma Treatment Gets FDA Blessing
On May 13, 2026, the Food and Drug Administration granted accelerated approval to sonrotoclax (Beqalzi, BeOne Medicines USA, Inc.), a BCL-2 inhibitor, for adults with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton's tyrosine kinase (BTK) inhibitor.
Clinical Trial Results
ORR was 52% (95% CI: 42, 62), with a median time to response of 1.9 months. The median DOR was 15.8 months (95% CI: 7.4, not estimable), after an estimated median follow-up of 11.9 months.
Significance
This application was granted priority review, breakthrough designation, and orphan drug designation.