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Gilteritinib is an oral small molecule tyrosine kinase inhibitor that selectively inhibits FMS-like tyrosine kinase 3 (FLT3) and AXL receptor tyrosine kinases. It is primarily used for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) harboring FLT3 mutations. Gilteritinib blocks FLT3 receptor signaling and inhibits the proliferation of leukemia cells with FLT3-ITD and TKD mutations, inducing apoptosis in these cells. The drug was developed by Astellas Pharma and was first approved by the US FDA in November 2018 for this indication. In China, it is marketed as Xospata/适加坦 and received conditional approval in January 2021 for treating relapsed or refractory AML with FLT3 mutations[1][4][5][6].
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