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Cytarabine + daunorubicin (or idarubicin) + gilteritinib is a combination chemotherapy regimen used for the treatment of newly diagnosed FLT3-mutated acute myeloid leukemia (AML). This regimen integrates the standard '7+3' induction chemotherapy backbone—consisting of the antimetabolite cytarabine and an anthracycline (either daunorubicin or idarubicin)—with gilteritinib (Xospata), a potent oral small-molecule tyrosine kinase inhibitor. Gilteritinib selectively targets both internal tandem duplication (ITD) and tyrosine kinase domain (TKD) mutations of the FMS-like tyrosine kinase 3 (FLT3) receptor, as well as the AXL kinase, which is associated with resistance to FLT3 inhibitors. The combination aims to provide synergistic antileukemic activity by combining broad cytotoxic effects with targeted inhibition of key survival pathways in FLT3-mutated blasts. It is currently being evaluated in Phase III clinical trials as a standard-of-care comparator against novel triplet regimens.
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