The FDA has granted accelerated approval to Beqalzi (sonrotoclax) for adults with relapsed or refractory mantle cell lymphoma (MCL) after at least two prior lines of systemic therapy, including a BTK inhibitor. The decision makes sonrotoclax the first BCL2 inhibitor specifically approved for this indication in the U.S., following outcomes from the phase 1/2 BGB-11417-201 trial. Beqalzi achieved an overall response rate of 52% (95% CI 42%–62%) with a 16% complete response rate. Median time to response was 1.9 months, and median duration of response was 15.8 months at a median follow-up of 11.9 months, according to trial results cited in the approval notice. The label includes warnings for tumor lysis syndrome, serious infections, neutropenia, and embryo-fetal toxicity; lab/clinical tumor lysis syndrome occurred in 7% of patients who followed the recommended dose ramp-up schedule. Continued approval is contingent on confirmation of clinical benefit in the ongoing phase 3 CELESTIAL-RRMCL trial. Michael Wang, MD, of MD Anderson, said the approval provides “an important new option” that changes how clinicians think about sequencing treatment in MCL.