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. The approval was supported by results from Be One Medicines’ Phase 1/2 BGB-11417-201 trial. Lilly said the trial showed an overall response rate of 52% and complete responses of 16%, with a median time to response of 1.9 months and a median duration of response of 15.8 months at median follow-up of 11.9 months. Continued approval depends on confirmation of clinical benefit in the ongoing Phase 3 CELESTIAL-RRMCL study. The prescribing information includes boxed and significant safety warnings, including tumor lysis syndrome, serious infections, neutropenia, and embryo-fetal toxicity. For oncology teams, the decision adds another targeted option to address limited post-BTK sequencing choices in MCL.