FDA has granted accelerated approval to Beqalzi (sonrotoclax), the first BCL-2 inhibitor specifically approved for relapsed or refractory mantle cell lymphoma in the US. The approval covers adults who have received at least two prior lines of systemic therapy, including a BTK inhibitor, reflecting the ongoing need for options after BTK inhibitor progression. The decision, issued May 13, 2026, is supported by results from BeOne Medicines’ phase 1/2 BGB-11417-201 trial. In treated patients, the overall response rate was 52% with a complete response rate of 16%, and median time to response was 1.9 months. Median duration of response was 15.8 months at a median follow-up of 11.9 months. The label includes safety warnings for tumor lysis syndrome, serious infections, neutropenia, and embryo-fetal toxicity. Tumor lysis syndrome was reported in 7% of patients following the recommended dose ramp-up schedule, while pneumonia and fatigue were among the most common adverse effects. Continued approval is contingent on confirmation of clinical benefit in the ongoing phase 3 CELESTIAL-RRMCL trial.