The European Commission grants approval to gilteritinib for patients with relapsed/refractory FLT3-positive acute myeloid leukemia (AML)

On the 28^th 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