The FDA granted accelerated approval to Beqalzi (sonrotoclax) for adults with relapsed or refractory mantle cell lymphoma after at least two prior systemic therapies, including a BTK inhibitor. The approval marks the first U.S. authorization of a BCL2 inhibitor specifically for MCL and was supported by Phase 1/2 trial results. In treated patients, the overall response rate was 52%, including a 16% complete response rate. The median time to response was 1.9 months, with a median duration of response of 15.8 months at median follow-up of 11.9 months. Safety warnings include tumor lysis syndrome, serious infections, neutropenia, and embryo-fetal toxicity, with laboratory or clinical tumor lysis syndrome reported in 7% under the recommended dose ramp-up. Continued approval depends on confirmatory benefit in the Phase 3 CELESTIAL-RRMCL trial.