BeOne Medicine has received accelerated approval from the FDA for once-daily Beqalzi (sonrotoclax) tablets, due to the medication’s enhanced BCL2 inhibition compared to other drugs in its class.
Beqalzi is the first approved BCL2 inhibitor to treat relapsed or refractory (R/R) mantle cell lymphoma (MCL). It will be available to adults who have received at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor. It is designed to be more potent, selective, and convenient with greater efficacy and tolerability.
The accelerated approval for Beqalzi is based on the phase 1/2 BGB-11417-201 trial. The drug led to an overall response rate of 52%, a complete response rate of 16%, a median time to response of 1.9 months, and a median duration response of 15.8 months (not yet at full maturity). The drug was also generally well tolerated, although with serious adverse reactions in 37% of participants. For continued approval, Beqalzi will need to demonstrate clinical benefit in the CELESTIAL-RRMCL trial.