News|Articles|May 13, 2026

FDA Approves Beqalzi for Relapsed Mantle Cell Lymphoma

Fact checked by: Alex Biese

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Key Takeaways

FDA accelerated approval covers relapsed/refractory MCL after ≥2 lines including a BTK inhibitor, positioning sonrotoclax as a potential first-in-class BCL-2 option in this setting.
Single-arm multicenter data showed ORR 52%, median time to response 1.9 months, and median duration of response 15.8 months, supporting clinically meaningful activity post-BTK exposure.
High-risk biology appeared responsive, with TP53-mutant patients achieving ORR 59.1%, suggesting potential utility where outcomes are typically poor.
Safety included serious adverse reactions in 37% (pneumonia 10%); labeling highlights TLS, serious infections, and neutropenia, with a four-week ramp-up before 320 mg daily dosing.
Continued approval remains contingent on confirmatory evidence of clinical benefit; review leveraged Project Orbis and priority review, following breakthrough and orphan drug designations.

FDA grants accelerated approval to Beqalzi (sonrotoclax) for relapsed or refractory mantle cell lymphoma in adults after prior therapies

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Beqalzi (sonrotoclax) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL).

The approval, announced by the agency on May 13, specifically indicates the drug for patients who have received at least two lines of systemic therapy, which must include a Bruton's tyrosine kinase (BTK) inhibitor. Developed by BeOne Medicines USA, Inc., Beqalzi is a next-generation BCL-2 inhibitor designed to target the aggressive B-cell malignancy.

Mantle cell lymphoma is a rare and aggressive form of non-Hodgkin lymphoma that accounts for approximately 5% of cases globally. Because nearly all patients eventually develop refractory or relapsed disease, and the five-year survival rate remains approximately 50%, the oncology community has long identified an urgent need for new therapeutic options.

“Achieving deep and durable responses in relapsed or refractory mantle cell lymphoma after BTK inhibitor therapy has been a long-standing challenge,” said Dr. Michael Wang, a professor at The University of Texas MD Anderson Cancer Center and the study’s presenting author, in a news release. Wang noted that the findings suggest this next-generation inhibitor could play a "foundational role" in improving outcomes for those with limited options.

The FDA’s decision was based on results from the BGB-11417-201 trial, a single-arm, multicenter study involving 103 adults. Clinical data showed an overall response rate (ORR) of 52%, with a median time to response of 1.9 months. The median duration of response was 15.8 months.

Notably, the drug demonstrated efficacy in patients with high-risk disease subtypes, including those with the TP53 mutation, a marker often associated with poor prognosis. In this specific subgroup, the ORR reached 59.1%. BeOne Medicines noted that Beqalzi could become the first BCL-2 inhibitor indicated for relapsed or refractory MCL in the United States.

The drug's safety profile was evaluated in 115 patients. Serious adverse reactions occurred in 37% of participants, with pneumonia being the most frequent (10%). The prescribing information includes specific warnings regarding tumor lysis syndrome (TLS), serious infections and neutropenia. To mitigate the risk of TLS, the recommended dosage begins with a four-week ramp-up phase, followed by a daily oral dose of 320 mg.

The approval was granted under Project Orbis, an initiative by the FDA Oncology Center of Excellence that allows for concurrent submission and review of oncology drugs among international partners. During this process, the FDA collaborated with the European Medicines Agency as an official observer. The application was also granted priority review, following previous breakthrough and orphan drug designations.

Amit Agarwal, Chief Medical Officer of Hematology at BeOne, stated in the news release that the clinical data "redefines what physicians can expect" from this class of treatment. Agarwal emphasized that Beqalzi has demonstrated success in achieving durable responses where previous therapies may have failed.

Ongoing studies are also exploring Beqalzi in combination with other therapies for different B-cell malignancies, such as chronic lymphocytic leukemia (CLL), where early trials have reportedly shown "unprecedented rates" of undetectable minimal residual disease.

For now, the accelerated approval provides a new pathway for MCL patients who have exhausted standard BTK inhibitor treatments. Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trials.

Editor's note: This article is for informational purposes only and is not a substitute for professional medical advice, as your own experience will be unique. Use this article to guide discussions with your oncologist. Content was generated with AI, reviewed by a human editor, but not independently verified by a medical professional.