The FDA approved Beqalzi (sonrotoclax), described as the first BCL2 inhibitor specifically approved for relapsed or refractory mantle cell lymphoma after at least two prior lines of systemic therapy, including a BTK inhibitor. The decision came as an accelerated approval based on Phase 1/2 trial results. The program reportedly achieved a 52% overall response rate with a 16% complete response rate in the studied population. The label includes safety warnings around tumor lysis syndrome, serious infections, neutropenia, and embryo-fetal toxicity. The FDA approval is contingent on confirmation of clinical benefit in an ongoing Phase 3 trial (CELESTIAL-RRMCL). Clinicians will likely focus on response durability and the balance of benefit versus hematologic and infectious risks. For oncology stakeholders, this approval expands the sequencing options for a setting where treatment after BTK failure has remained limited, and it adds competitive pressure for other BCL2 and apoptosis-pathway strategies.