FDA to reconsider rare cancer drug Ebvallo after surprise rejection

FDA to reconsider rare cancer drug Ebvallo after surprise rejection

statnews.com • • business

Key Points:

  • Pierre Fabre Pharmaceuticals and Atara Biotherapeutics reached an agreement with the FDA regarding their rare blood cancer therapy, Ebvallo.
  • The FDA reversed its primary reason for rejecting the drug in January after a meeting in late April.
  • The agency agreed that the completed single-arm clinical trial data is sufficient to support review and potential approval of Ebvallo.
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