BeOne Medicines Gets Breakthrough Therapy Designation for Sonrotoclax

By Chris Wack

BeOne Medicines said the Food and Drug Administration has granted Breakthrough Therapy Designation for sonrotoclax for the treatment of adult patients with relapsed or refractory mantle cell lymphoma.

The oncology company on Monday said the FDA has also accepted its 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.

The decision by the FDA to grant sonrotoclax Breakthrough Therapy Designation and participation in Project Orbis was based on data from a phase 1/2 study evaluating sonrotoclax in adult patients with mantle cell lymphoma, following treatment with a Bruton's tyrosine kinase inhibitor and anti-CD20 therapy.

The FDA grants Breakthrough Therapy Designation to medicines with early data suggesting they may offer significant advances for patients with serious diseases.

Project Orbis, established by the FDA Oncology Center of Excellence in 2019, facilitates collaboration across regulatory bodies on the review of oncology medicines with the goal of making promising cancer therapies available to patients more quickly across participating countries.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

October 13, 2025 06:45 ET (10:45 GMT)