Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that FLT3-ITD status confers therapeutic sensitivity to Gilteritinib in patients with Acute Myeloid Leukemia.
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.
This statement is based on a regulatory approval from the European Medicines Agency:
Xospata is indicated as monotherapy for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia (AML) with a FLT3 mutation.