Onco-Summaries: Daily Oncology Updates at a Glance

26/11/2025

BeOne's sonrotoclax received the priority review status for R/R MCL (Ref)

The US FDA granted priority review status to BeOne Medicines' NDA for sonrotoclax (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 results from the global Phase 1/2 BGB-11417-201 (NCT05471843) trial

• Lai Wang, Ph.D., Global Head of R&D, BeOne: “Sonrotoclax is advancing with remarkable speed, from Breakthrough Therapy Designation to Priority Review, all within a short window. That pace reflects both the strength of the data and the urgency of the need for patients with R/R MCL. With rapid, deep, and durable responses and a manageable safety profile, sonrotoclax is emerging as a potential best-in-class BCL2 inhibitor, alongside our two other transformative hematology assets – BTK inhibitor BRUKINSA, and investigational BTK degrader BGB-16673.”