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 24, but noted the agency did not request additional safety or efficacy data
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