FDA grants accelerated approval to sonrotoclax for relapsed/refractory mantle cell lymphoma

The U.S. Food and Drug Administration has granted accelerated approval to sonrotoclax (brand name Beqalzi) for adult patients with relapsed or refractory mantle cell lymphoma who have received at least two prior systemic therapies, including a BTK inhibitor.

The approval is based on the phase 1/2 BGB-11417-201 trial, which enrolled 103 patients previously treated with anti‑CD20 therapy and a BTK inhibitor. The study reported an overall response rate of 52%, a median time to response of 1.9 months, and a median duration of response of 15.8 months after a median follow-up of 11.9 months.

Safety findings showed serious adverse events in 37% of participants, with pneumonia occurring in 10% of patients. The product label highlights risks of tumor lysis syndrome, serious infections, and neutropenia.