FDA questions credibility of Daiichi data

The FDA has moved back the PDUFA action date to August for Daiichi Sankyo’s quizartinib, used for the treatment of acute myeloid leukemia (AML). Current Phase 3 data, linked FLT3 inhibitor quizartinib to a 1.5 month improvement in overall survival (OS) over chemotherapy.

Daiichi filed for FDA approval on the strength of the trial results, but it looks like the FDA needs more time for evaluation.

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