BeOne Medicines Receives U.S. FDA Priority Review for Sonrotoclax in Relapsed or Refractory Mantle Cell Lymphoma
Thursday, November 27, 2025
BeOne Medicines Ltd. has announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review to the New Drug Application for sonrotoclax, a next-generation BCL2 inhibitor intended for adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have previously received a Bruton’s tyrosine kinase (BTK) inhibitor.
Mantle cell lymphoma (MCL) is a rare and aggressive form of non-Hodgkin lymphoma that develops from B-cells in the mantle zone of lymph nodes. It represents around 5 per cent of non-Hodgkin lymphoma cases worldwide, affecting an estimated 28,000 people. MCL is often diagnosed at an advanced stage, and most patients eventually experience relapse or resistance to treatment. The five-year survival rate is roughly 50 per cent, highlighting the need for new and effective therapies.
Sonrotoclax is an investigational, next-generation BCL2 inhibitor designed to target B-cell malignancies. Early research shows that it is a highly potent and selective BCL2 blocker with a short half-life and no drug accumulation. It is being developed as both a monotherapy and in combination with other treatments, including the BTK inhibitor BRUKINSA.
The submission is supported by results from a global Phase 1/2 study (BGB-11417-201), which enrolled 125 adults with relapsed or refractory MCL. The study met its primary endpoint, showing a meaningful overall response rate based on independent assessment. Secondary outcomes, including complete response rate, duration of response, and progression-free survival, also showed encouraging results. The treatment demonstrated a manageable safety profile in a heavily pre-treated patient group.
In China, applications for sonrotoclax for MCL and CLL/SLL are currently under review for potential accelerated approval.
The company is also participating in the FDA’s Project Orbis to support faster global review and is preparing further submissions to international regulatory agencies, including the European Medicines Agency.
Source: beonemedicines.com
