NEW YORK – The European Commission has approved gilteritinib (Astellas' Xospata) as a treatment for adult acute myeloid leukemia who have relapsed or refractory disease characterized by FLT3 mutations.
The drug has shown in clinical trials that it can improve outcomes in AML patients with FLT3 internal tandem duplication (ITD) and tyrosine kinase domain (TKD) mutations, which are the most common in this setting. The EC approved the drug based on results of the randomized, Phase III ADMIRAL study, which were published today in the New England Journal of Medicine, and showed an average overall survival of 9.3 months in FLT3-mutated AML patients treated with gilteritinib compared to 5.6 months in those treated with salvage chemotherapy.
"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," Giovanni Martinelli from the S. Orsola-Malpighi University Hospital in Bologna, Italy, and an investigator in the ADMIRAL trial, said in a statement. "Gilteritinib is a new and clinically meaningful treatment option that provides a welcome advance for patients and healthcare professionals across the European Union."
EC approval enables Astellas to market the drug in EU member countries, as well as in Iceland, Norway and Liechtenstein.
The US Food and Drug Administration last year approved gilteritinib for the same indication alongside Invivoscribe Technologies' LeukoStrat CDx companion diagnostic for identifying FLT3 mutations.
With the EC approval, Invivoscribe also issued a statement highlighting that its LeukoStrat CDx FLT3 Mutation Assay was developed in partnership with Astellas, used in the ADMIRAL trial, and can identify AML patients with FLT3 ITD and TKD mutations who are likely to respond to gilteritinib.
Testing is available as a service through its LabPMM subsidiaries in San Diego, Germany, and Japan, and test kits are distributed in Europe, Japan, Switzerland, and Australia. The company plans to distribute LeukoStrat CDx FLT3 Mutation Assay kits in the US and in China in the future.