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Ambit will not seek accelerated approval for quizartinib based on Phase 2 data

  • Ambit Biosciences (AMBI) will not submit an NDA for accelerated approval of
    quizartinib based on Phase 2 and Phase 2b data as the FDA does not agree that CR with incomplete hematologic recovery "represents a surrogate endpoint reasonably likely to predict clinical benefit."
  • After getting feedback from the regulator, the company still plans to "conduct a randomized, controlled Phase 3 clinical trial in relapsed/refractory FLT3-ITD positive AML patients."
  • OS will be the endpoint.
  • The company says it "remains committed to moving quizartinib through its late stage development as expeditiously as possible." (PR)
  • Shares are halted.
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Comments (1)
  • toosmarttofail
    , contributor
    Comments (610) | Send Message
     
    The FDA sure doesn't like new drugs these days, just as Big Pharma stocks are at all-time highs.
    5 Dec 2013, 12:22 AM Reply Like
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