U.S. FDA Grants Priority Review to Sonrotoclax for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma
News Source : Financial Post
News Summary
- The U.S. Food and Drug Administration has accepted and granted Priority Review to a New Drug Application (NDA) for sonrotoclax, a next-generation BCL2 inhibitor.
- The NDA is supported by data from the global, multicenter, single-arm, open-label, Phase 1/2 study, BGB-11417-201.
- 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.
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 cancerTHIS CONTENT IS RESERVED FOR SUBSCRIBERS ONLYSubscribe n [+9698 chars]
Never miss a story from us, subscribe to our newsletter