The U.S. Food and Drug Administration (FDA) on Wednesday granted accelerated approval to BeOne Medicines Ltd.‘s (NASDAQ:ONC) Beqalzi (sonrotoclax) for adults with relapsed or refractory mantle cell lymphoma who previously received at least two lines of systemic therapy, including a Bruton’s tyrosine kinase inhibitor.
The approval adds a new treatment option for patients with limited therapies after disease progression.
FDA Clears BEQALZI For Post-BTK Mantle Cell Lymphoma
The company described BEQALZI as a next-generation BCL2 inhibitor designed to improve potency, selectivity, and convenience compared with existing therapies in the class.
Data from the Phase 1/2 BGB-11417-201 study supported the FDA's decision. Independent review data showed an overall response rate of 52% and a complete response rate of 16%.
The study also reported a median time to response of 1.9 months and a median duration of response of 15.8 months. Patients tolerated the therapy well in monotherapy treatment.
The accelerated approval remains contingent on confirmation of clinical benefit in the ongoing CELESTIAL-RRMCL confirmatory trial.
Mantle cell lymphoma is a rare and aggressive form of non-Hodgkin lymphoma. Around 3,300 new cases are diagnosed annually in the U.S. Relapse remains common, especially after treatment with BTK inhibitors.
The drug is expected to launch in the second half of 2026, a company spokesperson told Reuters.
Additional Regulatory Reviews Underway
China approved Beqalzi for relapsed or refractory mantle cell lymphoma as well as certain chronic lymphocytic leukemia and small lymphocytic lymphoma patients.
BeOne said regulators in Europe and other regions are reviewing the therapy. Sonrotoclax is also being studied in combination with other treatments, including zanubrutinib, for chronic lymphocytic leukemia, with updated data expected at the 2026 American Society of Clinical Oncology Annual Meeting.
ONC Price Action: BeOne Medicines shares were down 3.33% at $306 at the time of publication on Thursday, according to Benzinga Pro.
Over the past month, ONC has gained about 1.3% versus a 8.8% rise in the S&P 500 and is up roughly 2% year-to-date compared to the index’s 9.1% gain.
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