Overview
- The FDA, which announced the action Wednesday, cleared Beqalzi for adults with relapsed or refractory mantle cell lymphoma after at least two prior treatments that included a BTK inhibitor.
- The decision is based on the phase 1/2 BGB-11417-201 study, where 52% of 103 eligible patients responded to sonrotoclax, with a median time to response of 1.9 months.
- At a median follow-up of 11.9 months, the median duration of response reached 15.8 months, indicating responses that can last more than a year for many patients.
- Safety results from 115 treated patients showed serious adverse events in 37%, most often pneumonia at 10%, and the label carries warnings for tumor lysis syndrome, serious infections, and neutropenia.
- Continued approval hinges on confirmatory benefit, with a phase 3 trial testing zanubrutinib plus sonrotoclax versus placebo in previously treated mantle cell lymphoma now underway.