The FDA granted accelerated approval to Beqalzi (sonrotoclax), the first BCL2 inhibitor specifically for relapsed or refractory mantle cell lymphoma (MCL) after at least two prior lines of systemic therapy, including a BTK inhibitor. The approval was supported by Phase 1/2 trial results from BGB-11417-201. Beqalzi achieved an overall response rate of 52% (95% CI, 42%–62%), including a complete response rate of 16%, with median time to response of 1.9 months and median duration of response of 15.8 months at median follow-up of 11.9 months. The label includes tumor lysis syndrome, serious infections, neutropenia, and embryo-fetal toxicity warnings. The FDA’s decision is contingent on confirmatory evidence from the ongoing Phase 3 CELESTIAL-RRMCL study. Clinically, the approval adds a new sequencing option for patients who progress on BTK inhibition, where treatment choices remain constrained by limited efficacy data.