Beigene's Sotigalimab has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration

Zhitong
2025.10.13 10:11

This recognition is based on the early positive results of a Phase 1/2 study of Sotokimab in patients with relapsed or refractory mantle cell lymphoma. Beigene will participate in the Orbis program to support the rapid advancement of the global accessibility of the drug. San Carlos, California, USA - Beigene, Ltd., a global innovative biotechnology company focused on cancer treatment, today announced that the U.S. Food and Drug Administration (FDA) has granted Sotokimab Breakthrough Therapy Designation for the treatment of adult patients with relapsed or refractory mantle cell lymphoma. In addition, the FDA has accepted Beigene's application to participate in the Orbis program. Under this program, anti-tumor drugs can be submitted for simultaneous application and review by participating global health authorities

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