U.S. FDA Grants Priority Review to Sonrotoclax for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma

Image for article 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]

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