06:50 AM EDT, 10/13/2025 (MT Newswires) -- BeOne Medicines ( ONC ) announced Monday that the US Food and Drug Administration has granted breakthrough therapy designation for sonrotoclax, its investigational therapy for the treatment of adult patients with relapsed or refractory mantle cell lymphoma.

The company said the designation is based on early clinical evidence from a phase 1/2 trial, which showed strong potential for deep and durable responses in certain patients.

Additionally, BeOne said the US health agency has accepted its application to participate in Project Orbis, an international initiative that enables the simultaneous review of oncology treatments by multiple regulatory agencies, to accelerate access to promising cancer therapies.