Therapeutic Response

FLT3 p.D835Y status confers therapeutic sensitivity to Gilteritinib in patients with Acute Myeloid Leukemia.

Statements

Source and description
Xospata (gilteritinib) [package insert]. FDA. The U.S. Food and Drug Administration granted approval to gilteritinib for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation, as detected by an FDA-approved test.
Xospata (gilteritinib) [product information]. EMA. The European Medicines Agency (EMA) has authorized gilteritinib for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation. Gilteritinib's product information states that, before taking gilteritinib, relapsed or refactory AML patients must have confirmation of FMS-like tyrosine kinase 3 (FLT3) mutation (internal tandem duplication [ITD] or tyrosine kinase domain [TKD]) using a validated test. The product information describes the mechanism of action for gilteritinib as inhibiting FLT3 receptor signaling and proliferation in cells exogenously expressing FLT3 including FLT3-ITD, FLT3-D835Y, and FLT3-ITD-D835Y, and that it induces apoptosis in leukemic cells expressing FLT3-ITD.