The FDA granted accelerated approval to Beqalzi (sonrotoclax), marking the first BCL2 inhibitor specifically approved for relapsed or refractory mantle cell lymphoma after at least two prior systemic therapies, including a BTK inhibitor. The approval was supported by results from the Phase 1/2 BGB-11417-201 trial, which reported an overall response rate of 52% and complete response rate of 16%, with a median duration of response of 15.8 months. The label includes safety warnings for tumor lysis syndrome and serious infections, and continued approval depends on confirmatory benefit in the ongoing Phase 3 CELESTIAL-RRMCL trial. For clinicians, the decision adds a new sequencing option in a setting with limited post-BTK choices and poor outcomes.