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.