Green-lighted in Japan, FDA quickly spurns Daiichi Sankyo's flawed application for AML drug
Three days after winning Japanese approval for its acute myeloid leukemia drug quizartinib, Daiichi Sankyo is being forced to endure an embarrassing rejection at the hands of the FDA.
US regulators wasted no time in batting back quizartinib after first highlighting the messy data in its application in an internal review, that in turn persuaded a large majority of outside experts to recommend a rejection for the drug, which targets FLT3-ITD–positive AML cases.
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