FDA grants accelerated approval to sonrotoclax for relapsed or refractory mantle cell lymphoma
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.
Full prescribing information for Beqalzi will be posted on Drugs@FDA .
Efficacy and Safety
Efficacy was evaluated in BGB-11417-201 (NCT05471843), a single-arm, multicenter trial in 103 adults with relapsed or refractory MCL who previously received anti-CD20-based therapy and a BTK inhibitor.
Efficacy was established based on overall response rate (ORR) and duration of response (DOR), as assessed by an independent review committee (IRC) using Lugano criteria. 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.
The prescribing information includes warnings and precautions for tumor lysis syndrome (TLS), serious infections, and neutropenia. Of 115 patients with MCL evaluated for safety, serious adverse reactions occurred in 37%, most frequently from pneumonia (10%).
Recommended Dosage
The recommended sonrotoclax regimen begins with a four-week ramp-up phase to reduce TLS risk, followed by 320 mg taken orally once daily until disease progression or unacceptable toxicity.
This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. FDA collaborated with the European Medicines Agency (EMA) as an official observer of this review. The applications may still be under review at the other regulatory agencies.
This application was granted priority review, breakthrough designation, and orphan drug designation. FDA expedited programs are described in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics.
Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.
For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact OCE’s Project Facilitate at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov .
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