Overview
- Sonrotoclax, sold as Beqalzi, won accelerated approval for adults with mantle cell lymphoma who have had at least two prior systemic therapies including a BTK inhibitor.
- Support for the decision came from a phase 1/2 study in 103 patients that showed a 52% overall response rate with 16% complete responses and a median time to response of 1.9 months.
- Responses lasted a median of 15.8 months at a median follow‑up of 11.9 months, according to the trial submitted to the FDA.
- Safety labeling warns about tumor lysis syndrome, serious infections, and neutropenia, and the drug uses a step‑up dosing schedule to lower the risk of sudden cell breakdown.
- Continued approval depends on results from the CELESTIAL‑RRMCL phase 3 trial, which is testing zanubrutinib with or without sonrotoclax in previously treated patients where options after BTK inhibitors are limited.