The FDA granted accelerated approval to BeOne Medicines’ sonrotoclax (Beqalzi), the first BCL2 inhibitor specifically indicated for adults with relapsed or refractory mantle cell lymphoma (MCL) after at least two prior lines of systemic therapy, including a BTK inhibitor. The decision, issued May 13, 2026, was supported by data from the phase 1/2 BGB-11417-201 trial. In the treated population, the overall response rate reached 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. Beqalzi’s label includes warnings for tumor lysis syndrome, serious infections, neutropenia, and embryo-fetal toxicity. Tumor lysis syndrome occurred in 7% of patients who followed the recommended dose ramp-up schedule, with pneumonia and fatigue reported as the most common adverse effects. Continued approval is contingent on confirmation of clinical benefit in the ongoing phase 3 CELESTIAL-RRMCL trial.