BeOne Medicines’ sonrotoclax granted Breakthrough Therapy Designation by FDA

BeOne Medicines (ONC) announced that the U.S. FDA has granted Breakthrough Therapy Designation for sonrotoclax, a next-generation and potentially best-in-class investigational BCL2 inhibitor, for the treatment of adult patients with relapsed or refractory mantle cell lymphoma. Additionally, the FDA has accepted BeOne’s request for participation in Project Orbis, an initiative that provides a framework for concurrent submission and review of oncology products among participating global health authorities.