Company : Astellas Pharma Inc
Approved by : FDA, EMA, NCCN
Approval Time : Nov. 28, 2018
Drug Type : Single-target inhibitor
Indications : Gilteritinib was approved 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, and was also approved for an expanded indication for a companion diagnostic, to include use with gilteritinib.
Mechanism Of Action :
Gilteritinib is a small molecule that inhibits multiple receptor tyrosine kinases, including FMS-like tyrosine kinase 3 (FLT3). Gilteritinib demonstrated the ability to inhibit FLT3 receptor signaling and proliferation in cells exogenously expressing FLT3 including FLT3-ITD, tyrosine kinase domain mutations (TKD) FLT3-D835Y and FLT3-ITD-D835Y, and it induced apoptosis in leukemic cells expressing FLT3-ITD.
Dosage : The recommended gilteritinib dose is 120 mg orally once daily.
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