The US FDA has granted accelerated approval to Beqalzi™ (sonrotoclax) for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor. This approval marks the first new BCL-2 inhibitor approved in the United States in a decade and the only BCL-2 inhibitor approved in MCL. Sonrotoclax is a next-generation BCL-2 inhibitor designed to promote apoptosis in malignant cells by selectively binding to the BCL-2 protein and displacing pro-apoptotic proteins.
The agent was developed to provide enhanced potency and selectivity, along with a short half-life and minimal drug accumulation. Clinical Evidence The accelerated approval is supported by findings from the Phase 1/2 BGB-11417-201 study (NCT05471843), which enrolled 103 adults with previously treated R/R MCL. All…
