BRUSSELS (dpa-AFX) - Astellas Pharma Inc. (ALPMY, ALPMY) announced Friday that the European Commission or EC has approved the oral once-daily therapy Xospata (gilteritinib) as a monotherapy for patients with relapsed or refractory acute myeloid leukemia or AML with a FLT3 Mutation.
The company noted that Gilteritinib has the potential to improve treatment outcomes for AML patients with two forms of the most common mutation-FLT3 internal tandem duplication or ITD and FLT3 tyrosine kinase domain or TKD mutation.
This approval is based on results from the Phase 3 ADMIRAL trial, which investigated gilteritinib versus salvage chemotherapy in patients with relapsed or refractory FLT3mut+ AML.
Patients treated with gilteritinib had significantly longer overall survival than those who received salvage chemotherapy.
Gilteritinib has been designated an orphan medicinal product and also received accelerated assessment from the European Medicines Agency earlier this year, which reduced the timeframe for approval.
Giovanni Martinelli, an investigator in the ADMIRAL trial, 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.'
Astellas said it reflected the impact from this approval in its financial forecast of the current fiscal year ending March 31, 2020.
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