The FDA granted accelerated approval to Beqalzi (sonrotoclax), becoming the first BCL2 inhibitor approved specifically for relapsed or refractory mantle cell lymphoma after at least two prior lines of systemic therapy, including a BTK inhibitor. BeOne Medicines’ approval came May 13, 2026, supported by results from its phase 1/2 BGB-11417-201 trial. In treated patients, Beqalzi delivered an overall response rate of 52% (95% CI: 42%–62%) with a complete response rate of 16%. Median time to response was 1.9 months and median duration of response was 15.8 months at a median follow-up of 11.9 months. Safety warnings in the prescribing information include tumor lysis syndrome, serious infections, neutropenia and embryo-fetal toxicity; tumor lysis syndrome occurred in 7% of patients following the recommended dose ramp-up. Continued approval is contingent on confirmation of clinical benefit in the ongoing phase 3 CELESTIAL-RRMCL trial.