FDA Approves BeOne's Beqalzi for Relapsed Mantle Cell Lymphoma

The Food and Drug Administration on May 13 granted accelerated approval to sonrotoclax (Beqalzi, BeOne Medicines), an oral 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, according to the agency's announcement.

BeOne said in its announcement, distributed by Business Wire and read via Via TT, that Beqalzi is the first and only BCL2 inhibitor approved in the US for relapsed or refractory MCL. Mantle cell lymphoma is a rare and often aggressive form of non-Hodgkin lymphoma; about 3,300 new cases are diagnosed in the US each year, the company said.

The trial behind the approval

The FDA based its decision on BGB-11417-201 (NCT05471843), a single-arm, multicenter trial in 103 adults with relapsed or refractory MCL who had previously received anti-CD20-based therapy and a BTK inhibitor. BeOne describes it as a Phase 1/2 study; its data were presented at the American Society of Hematology annual meeting.

The overall response rate was 52% (95% confidence interval 42 to 62), as assessed by an independent review committee, with a median time to response of 1.9 months, the FDA said. The median duration of response was 15.8 months after an estimated median follow-up of 11.9 months. BeOne reported a complete response rate of 16% and said the response data have yet to reach full maturity. The trial had no comparison arm.

The prescribing information includes warnings and precautions for tumor lysis syndrome, serious infections and neutropenia. Among 115 patients with MCL evaluated for safety, serious adverse reactions occurred in 37%, most often pneumonia (10%), according to the FDA. Treatment starts with a four-week dose ramp-up intended to reduce the risk of tumor lysis syndrome, followed by 320 mg once daily.

Targeted Oncology reported that the FDA had accepted the new drug application and granted it priority review in November 2025. The agency also granted the drug breakthrough designation and orphan drug designation for this use.

Conditions and next steps

Because the approval is accelerated, based on response rate and duration of response, continued approval may depend on confirmation of clinical benefit. BeOne said that confirmation is expected from the CELESTIAL-RRMCL trial (NCT06742996), which is under way.

"Today's approval of BEQALZI represents critical progress for patients with mantle cell lymphoma," said Amit Agarwal, BeOne's chief medical officer for hematology.

The FDA said the review was conducted under Project Orbis, its framework for concurrent review of cancer drugs with international partners, with the European Medicines Agency taking part as an official observer. BeOne said the data are under review by the EMA and other regulators, and that sonrotoclax is already approved in China for relapsed or refractory MCL and for chronic lymphocytic leukemia or small lymphocytic lymphoma after prior therapy including a BTK inhibitor.