BeOne Medicines’ Beqalzi granted accelerated approval by FDA

BeOne Medicines (ONC) announced that the U.S. Food and Drug Administration has granted accelerated approval to Beqalzi, a next-generation BCL2 inhibitor, for the treatment of adult patients with relapsed or refractory mantle cell lymphoma, after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase inhibitor. “Beqalzi was designed to enhance BCL2 inhibition-with greater potency, selectivity, and a pharmacologic profile with potential to improve efficacy, tolerability, and convenience over others in the class,” the company stated. Continued approval for this indication is contingent upon confirmation of clinical benefit in the confirmatory CELESTIAL-RRMCL trial, which is underway. The U.S. FDA granted Breakthrough Therapy Designation for sonrotoclax in this indication, as well as Fast Track Designation and Orphan Drug Designation.