FDA Recognises BEQALZI as a New Treatment Option
BeOne Medicines Ltd. has received accelerated approval from the U.S. Food and Drug Administration for BEQALZI (sonrotoclax), a new BCL2 inhibitor, for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor.
This approval marks the first time in a decade that a new BCL2 inhibitor has been approved in the United States. BEQALZI aims to set a new standard of innovation as it is the only BCL2 inhibitor approved for MCL.
BEQALZI was designed to enhance BCL2 inhibition with greater potency, selectivity, and a pharmacologic profile that could improve efficacy, tolerability, and convenience over others in the class.
Michael Wang, M.D., Global Principal Investigator at The University of Texas MD Anderson Cancer Center, stated, "The data supporting the approval of sonrotoclax in the U.S. confirm its role as a foundational therapy for mantle cell lymphoma in the post-BTK inhibitor setting."
Phase 1/2 Study and Results
The Phase 1/2 study, BGB-11417-201, demonstrated an overall response rate of 52% with a complete response rate of 16%. The median time to response was 1.9 months, and the median duration of response was 15.8 months.
The study results were presented at the 67th American Society of Hematology Annual Meeting & Exposition. Treatment with sonrotoclax monotherapy was generally well tolerated.
BEQALZI has also been approved in China for relapsed or refractory MCL and is under review by the European Medicines Agency. It has received Fast Track Designation and Orphan Drug Designation in the U.S. for multiple indications.
Continued approval of BEQALZI may depend on the results of the ongoing CELESTIAL-RRMCL trial. The U.S. FDA has granted Breakthrough Therapy Designation for sonrotoclax in mantle cell lymphoma.
Amit Agarwal, M.D., Ph.D., Chief Medical Officer at BeOne Medicines, noted, "Today’s approval of BEQALZI represents critical progress for patients with mantle cell lymphoma."
For patients who have exhausted other therapies, this approval provides new hope for managing this challenging condition.
Last updated: 14 May 2026, 9:50 am
