On November 28, 2018, the Food and Drug Administration approved gilteritinib tablets for oral use for treatment of adult patients who have relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation as detected by an FDA-approved test.
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Gilteritinib is used to treat acute myeloid leukemia with an FMS-like tyrosine kinase 3 (FLT3) mutation that has come back or has not improved after previous treatments.Gilteritinib is in a class of medications called kinase inhibitors. It works by blocking the action of a certain naturally occurring substance that may be needed to help cancer cells multiply.

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