- 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.
From other sites
at MarketWatch.com (Sep 29, 2014)
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