BeOne Medicines says FDA grants Priority Review to NDA for sonrotoclax

BeOne Medicines (ONC) announced that the U.S. FDA has accepted and granted Priority Review to a New Drug Application for sonrotoclax, a next-generation BCL2 inhibitor, for the treatment of adult patients with relapsed or refractory mantle cell lymphoma, following treatment with a Bruton’s tyrosine kinase inhibitor. Supporting efforts to rapidly advance global review and potential access, BeOne will participate in the FDA’s Project Orbis for sonrotoclax, an initiative that provides a framework for concurrent submission and review of oncology products among international partners. BeOne also intends to submit the Phase 1/2 data to other global regulatory bodies for the potential approval of sonrotoclax in R/R MCL, including the European Medicines Agency.