The US Food and Drug Administration has granted accelerated approval to sonrotoclax, a BCL-2 inhibitor, for adults with relapsed or refractory mantle cell lymphoma after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase inhibitor.
The decision was based on the results of 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.
In the trial, efficacy was assessed by an independent review committee using Lugano criteria. The overall response rate was 52%, with a median time to response of 1.9 months. The median duration of response was 15.8 months, 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%).
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.
