FDA Grants Priority Review to BeOne Medicines' Sonrotoclax for Relapsed or Refractory Mantle Cell Lymphoma

Reuters11-26

FDA Grants Priority Review to BeOne Medicines' Sonrotoclax for Relapsed or Refractory Mantle Cell Lymphoma

The U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to the New Drug Application (NDA) submitted by BeOne Medicines AG for sonrotoclax, a next-generation BCL2 inhibitor, for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma (MCL) following treatment with a Bruton's tyrosine kinase (BTK) inhibitor. The NDA is supported by positive data from a global Phase 1/2 study in this patient population. Sonrotoclax is also under regulatory review for R/R MCL and R/R chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) by the Center for Drug Evaluation $(CDE)$ of the China National Medical Products Administration (NMPA), with potential for accelerated approval. Additionally, BeOne intends to submit data to other global regulatory bodies, including participation in the FDA's Project Orbis initiative for concurrent international review.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. BeOne Medicines AG published the original content used to generate this news brief via Business Wire (Ref. ID: 20251126490630) on November 26, 2025, and is solely responsible for the information contained therein.

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