Sonrotoclax granted priority review by the U.S. FDA for the treatment of relapsed or refractory mantle cell lymphoma

BeOne Medicines has announced that the U.S. FDA has accepted and granted Priority Review to a NDA for sonrotoclax, a next-generation BCL2 inhibitor, for the treatment of adult patients with relapsed or refractory (R/R) mantle cell lymphoma, following treatment with a Bruton’s tyrosine kinase (BTK) inhibitor.

“Sonrotoclax is advancing with remarkable speed, from Breakthrough Therapy Designation to Priority Review, all within a short window,” said Lai Wang, Ph.D., Global Head of R&D at BeOne. “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.”

Note that the NDA is supported by data from the global, multicenter, single-arm, open-label, Phase 1/2 study, BGB-11417-201, which enrolled 125 adult patients with R/R MCL who received prior treatment with a BTK inhibitor. Sonrotoclax achieved its primary endpoint of overall response rate as assessed by an independent review committee, demonstrating clinically meaningful responses in this heavily pretreated population. The study also showed promising results across several secondary efficacy endpoints, including complete response rate, duration of response, and progression-free survival.

NDA’s for sonrotoclax for the treatment of R/R MCL and R/R chronic lymphocytic leukemia / small lymphocytic lymphoma have also been accepted and are under review by the Center for Drug Evaluation of the China National Medical Products Administration for potential accelerated approval.

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Related Topics and Keywords

be one, beoone, FDA, mantle cell lymphoma, Relapsed or Refractory Mantle Cell Lymphoma, Sonrotocla