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

Oct 29, 2019

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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

  1. Pharmaphorum. Astellas gets EU approval for AML drug Xospata. Published; October 28 2019, [Accessed October 28 2019]
  2. U.S. Food and Drug Administration. FDA approves gilteritinib for relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation. [Accessed October 28 2019]
  3. European Medicines Agency. Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 September 2019. Published; September 20 2019, [Accessed October 28 2019]


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