Gilteritinib can be used in the treatment of AML patients whose disease is in the relapsed or refractory stage, and who express a FLT3 mutation (FLT3mut+).
The oral once-daily therapy was approved in the US and Japan in 2018 for the same indication. In the same year, the drug was granted orphan designation from the EC for AML, which is a cancer that affects the blood and bone marrow.
According to Astellas, the drug has the potential to boost treatment outcomes for AML patients with two types of the most common mutation in the form of the FLT3 internal tandem duplication (ITD) and FLT3 tyrosine kinase domain (TKD) mutation.
Astellas senior vice president and oncology development global therapeutic area head said: “Today’s approval marks a significant advance for patients living with relapsed or refractory, FLT3 mutation-positive acute myeloid leukaemia.
“We look forward to working with health authorities across the EU to bring gilteritinib to patients who need it the most, as soon as possible.”
The European approval for the AML drug has been given on the basis of the data from the Phase 3 ADMIRAL trial. The late-stage trial investigated Astellas’ drug in comparison to salvage chemotherapy in patients having relapsed or refractory FLT3mut+ AML.
The ADMIRAL trial showed that patients treated with gilteritinib had substantially longer overall survival (OS) than those who were subjected to salvage chemotherapy.
The Median OS for patients who were administered Astellas’ drug was 9.3 months, while the OS in the salvage chemotherapy arm was 5.6 months. The rates of one-year survival in the gilteritinib arm were 37% and for the salvage chemotherapy group, it was 17%.
ADMIRAL trial’s investigator Giovanni Martinelli said: “AML is a rare cancer and patients with a FLT3 mutation have a particularly poor prognosis, with a median survival of less than six months following treatment with salvage chemotherapy.
“Gilteritinib is a new and clinically meaningful treatment option that provides a welcome advance for patients and health care professionals across the European Union.”