U.S. FDA Grants Priority Review to Sonrotoclax for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma
BeOne Medicines Ltd. - American Depositary Shares (ONC)
Company Research
Source: Business Wire
If approved, sonrotoclax will become the first BCL2 inhibitor for R/R MCL in the U.S., addressing a high unmet need in an aggressive cancerSonrotoclax previously received Breakthrough Therapy Designation based on clinically meaningful, rapid responses in R/R MCLBeOne Medicines will present the data supporting the NDA and Priority Review for the first time at ASH 2025 SAN CARLOS, Calif.--(BUSINESS WIRE)--BeOne Medicines Ltd. (Nasdaq: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review to a New Drug Application (NDA) 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.“Sonrotoclax is advancing with remarkable speed, from Breakthrough Therapy Designation to Priority Review, all within a short window,” said Lai W
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- 11/14/25 - Form 4
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