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On the 28th of October 2019 the European Commission approved gilteritinib for the treatment of FLT3-mutated relapsed/refractory (R/R) acute myeloid leukemia (AML) which represent around 30% of all patients with AML and is often associated with a worse prognosis.1
Gilteritinib was approved by the U.S. Food & Drug Administration (FDA) in November 20182 and received positive recommendation from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) in September 2019.3
Gilteritinib is a second generation dual FLT3/AXL inhibitor and its approval is based on the ADMIRAL clinical trial (NCT02421939) in which participants were randomized to receive 120 mg/day of gilteritinib or salvage chemotherapy. This trial showed that gilteritinib improves overall survival (OS) compared to salvage chemotherapy with a median OS of 9.3 months for gilteritinib versus 5.6 months for chemotherapy.1
Gilteritinib reached the market after midostaurin, the first approved FLT3 inhibitor. Midostaurin, combined to chemotherapy, was approved for newly-diagnosed FLT3-positive AML in 2017. According to an investigator in the ADMIRAL trial “Gilteritinib is a new and clinically meaningful treatment option that provides a welcome advance for patients and health care professionals across the European Union.” 1
Gilteritinib receives positive recommendation from EMA CHMP for the treatment of FLT3-mutated AML
EMA CHMP recommends that gilteritinib is granted marketing authorization in Europe for the treatment of FLT3-mutated relapsed/refractory (R/R) acute...
Editorial theme | The value of FLT3 targeting in AML
FMS-like tyrosine kinase 3 (FLT3) is a transmembrane protein expressed by hematopoietic stem and progenitor cells and is involved in the early stages of lymphopoiesis and myelopoiesis. FLT3 gene...
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