BeOne Medicines announced that the US Food and Drug Administration (FDA) has accepted and granted Priority Review to a New Drug Application (NDA) for sonrotoclax, a next-generation BCL2 inhibitor, to treat adult patients with Relapsed or Refractory (R/R) Mantle Cell Lymphoma (MCL), following treatment with a Bruton’s Tyrosine Kinase (BTK) inhibitor.

“Sonrotoclax is advancing with remarkable speed, from Breakthrough Therapy Designation (BTD) 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,” said Lai Wang, PhD, Global Head—R&D, BeOne.

BeOne will present the full results for the first time at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition, December 6-9, in Orlando, Florida.

Supporting efforts to rapidly advance global review and potential access, the company will participate in the FDA’s Project Orbis for sonrotoclax, an initiative that provides a framework for concurrent submission and review of oncology products among international partners.

BeOne also intends to submit the Phase 1/2 data to other global regulatory bodies for the potential approval of sonrotoclax in R/R MCL, including the European Medicines Agency (EMA).

New Drug Applications (NDAs) for sonrotoclax for the treatment of R/R MCL and R/R Chronic Lymphocytic Leukemia / Small Lymphocytic Lymphoma (CLL/SLL) have also been accepted and are under review by the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) for potential accelerated approval.