The FDA granted accelerated approval to Beqalzi (sonrotoclax), a BCL-2 inhibitor from BeOne Medicines, for adults with relapsed or refractory mantle cell lymphoma (MCL) after at least two prior lines of systemic therapy, including a BTK inhibitor.
Beqalzi is described as the first BCL-2 inhibitor approved for this MCL setting, giving patients a new targeted option after prior therapy failure.
The approval was based on phase 1/2 data from the single-arm BGB-11417-201 study, which showed a 52% overall response rate, a 16% complete response rate, and a median duration of response of 15.8 months.
The FDA approval is under the accelerated approval pathway, so continued approval depends on confirmatory results from the ongoing phase 3 CELESTIAL-RRMCL trial.
Beqalzi is positioned as a Venclexta challenger and is BeOne’s third commercial product after Brukinsa and Tevimbra.