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FDA Extends Review for Quizartinib in Newly Diagnosed FLT3-ITD+ AML

The FDA has extended the review period for a new drug application for quizartinib in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, and as continuation monotherapy following consolidation, for the treatment of newly diagnosed adult patients with FLT3-ITD–positive acute myeloid leukemia. ....

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