Quizartinib Looks Like A Good Drug, ODAC Says, But Needs Another Efficacy Trial Before Approval

 
• By Michael Cipriano
  
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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.

The US Food and Drug Administration's Oncologic Drugs Advisory Committee (ODAC) felt that Daiichi Sankyo Co. Ltd.'s acute myeloid leukemia candidate quizartinib is not quite ready for market in voting against approval by an 8-3 margin at a 14 May meeting. But panelists felt there is a path forward for the drug if the sponsor can more adequately define its efficacy in another trial.

Daiichi is seeking approval for quizartinib to the treat of adults with relapsed or refractory AML which is FLT3-ITD positive,...

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