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Ambit Biosciences Provides Regulatory Update Following FDA Meeting Regarding Quizartinib (AC220)
Date:12/3/2013

SAN DIEGO, Dec. 3, 2013 /PRNewswire/ -- Ambit Biosciences (Nasdaq: AMBI), a biopharmaceutical company focused on discovery and development of drugs targeting unmet needs in oncology, autoimmune and inflammatory disease, today announced a regulatory update after receiving feedback from the U.S. Food and Drug Administration (FDA) on the development of quizartinib (AC220), the Company's lead drug candidate, for the treatment of relapsed/refractory acute myeloid leukemia (AML).

Based on feedback from the FDA, the Company continues to move forward with its baseline plan to conduct a randomized, controlled Phase 3 clinical trial in relapsed/refractory FLT3-ITD positive AML patients with an overall survival endpoint as the basis for the potential initial approval of quizartinib.  The Company is continuing to work with the FDA to refine the appropriate starting dose for the Phase 3 trial. 

The Company has been in dialogue with the FDA related to acceptance of a novel surrogate endpoint that could support accelerated approval based upon the results of the Company's Phase 2 and Phase 2b trials.  The FDA informed the Company it does not agree that complete remission with incomplete hematologic recovery (CRi) represents a surrogate endpoint reasonably likely to predict clinical benefit.  Based on the FDA's current position, the Company does not plan at this time to submit a NDA for accelerated approval of quizartinib based on the Phase 2 and 2b clinical trial data.

"We remain committed to moving quizartinib through its late stage development as expeditiously as possible, given the limited treatment options for FLT3 ITD positive AML patients who have relapsed or who are refractory to prior treatments.  We will continue to work with the clinical community and the FDA to achieve this goal," said

SOURCE Ambit Biosciences
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