The U.S. Food and Drug Administration has granted accelerated approval to Sonrotoclax for adults with relapsed or refractory Mantle Cell Lymphoma who have already received at least two previous treatments, including a BTK inhibitor.
The approval was based on results from the BGB-11417-201 trial involving 103 patients whose disease had returned after standard therapies. The treatment produced an overall response rate of 52%, rising to 61% in patients who had received fewer prior treatments. About 15.5% of patients achieved a complete response. Patients responded quickly, with a median response time of 1.9 months, and responses lasted a median of 15.8 months.
To reduce the risk of tumor lysis syndrome, patients start with a four-week dose ramp-up before moving to a daily 320 mg dose. Serious side effects occurred in 37% of patients, with pneumonia and neutropenia among the most common concerns.