Daiichi's AML Drug Quizartinib Heads To ODAC With Host Of Efficacy, Safety Issues
US FDA's Oncologic Drugs Advisory Committee will examine Daicchi Sankyo's acute myeloid lekemia drug quizartinib in the second of two half-day panels for the sponsor.
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The latest drug development news and highlights from our US FDA Performance Tracker.
Daiichi Sankyo made a strong case to rebut US FDA’s concerns about the 'credibility' of a survival benefit reported for its refractory AML therapy quizartinib in front of the Oncologic Drugs Advisory Committee. Then Richard Pazdur spoke.
US FDA's Oncologic Drugs Advisory Committee voted 8-3 against approval for Daiichi's quizartinib, although panelists felt the acute myeloid leukemia candidate would be approvable with another trial to better characterize its efficacy.