Posted by Michael Wonder on 13 Oct 2025
BeOne Medicines’ sonrotoclax granted breakthrough therapy designation by US FDA
13 October 2025 - Breakthrough designation based on early, positive results of a Phase 1/2 study of sonrotoclax in patients with relapsed or refractory mantle cell lymphoma.
BeOne Medicines today announced that the US 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.
This is the first breakthrough therapy designation for sonrotoclax and the second for BeOne’s haematology program. The FDA has also granted sonrotoclax fast track designation for mantle cell lymphoma and Waldenström's macroglobulinaemia.
