On May 13, the U.S. Food and Drug Administration (FDA) granted accelerated approval to sonrotoclax (Beqalzi), 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.
BGB-11417-201
Efficacy was evaluated in BGB-11417-201 (ClinicalTrials.gov identifier 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 and duration of response, as assessed by an independent review committee using Lugano criteria. The overall response rate was 52% (95% confidence interval [CI] = 42%–62%), with a median time to response of 1.9 months. The median duration of response was 15.8 months (95% CI = 7.4 months to not estimable), after an estimated median follow-up of 11.9 months.
The prescribing information includes warnings and precautions for tumor-lysis syndrome, serious infections, and neutropenia. Of 115 patients with MCL evaluated for safety, serious adverse reactions occurred in 37%, most frequently from pneumonia (10%).
The recommended sonrotoclax regimen begins with a 4-week ramp-up phase to reduce tumor-lysis syndrome, 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 which provides a framework for concurrent submission and review of oncology drugs among international partners. The FDA collaborated with the European Medicines Agency 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.
