Long Road For Daiichi Sankyo’s Quizartinib Gets Longer As FDA Extends Review Time

 
• By Alaric DeArment
  
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The drug could nevertheless find itself in a competitive position if approved for frontline FLT3-ITD acute myeloid leukemia, especially as competitor Astellas’s Xospata has repeatedly stumbled.

The FDA extended the PDUFA date for Daiichi Sankyo's quizartinib by three months • Source: Shutterstock

Daiichi Sankyo Co., Ltd.’s long-sought approval for quizartinib to treat FLT3-ITD acute myeloid leukemia (AML) faces another delay as the US Food and Drug Administration extended its verdict on the drug by three months in order to review updates it requested for the risk evaluation and mitigation strategies (REMS) in the drug maker’s approval application. But if quizartinib ultimately wins the agency’s nod, it could find itself in a competitive position.

The Japanese pharma company said 20 April that the FDA extended the original action date by three months, to July...

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