The FDA granted accelerated approval to Beqalzi (sonrotoclax) for adults with relapsed or refractory mantle cell lymphoma (MCL) who have received at least two prior lines of systemic therapy, including a BTK inhibitor. The approval marks the first U.S. authorization of a BCL2 inhibitor specifically for this setting. Results supporting the decision came from the Phase 1/2 BGB-11417-201 trial, with an overall response rate of 52% and complete responses in 16% of treated patients. 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. Continued approval is contingent on confirmation of clinical benefit in the ongoing Phase 3 CELESTIAL-RRMCL trial, placing the next inflection point on longer-term outcomes rather than response alone.