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Astellas Pharma Gets Positive CHMP Opinion For XOSPATA

Astellas Pharma Inc. said that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency or EMA has adopted a positive opinion recommending the oral once-daily therapy XOSPATA or gilteritinib as a monotherapy for the treatment of adult patients who have relapsed or refractory (resistant to treatment) acute myeloid leukemia or AML with a FLT3 mutation (FLT3mut+).

If approved by the European Commission, gilteritinib has the potential to improve treatment outcomes for AML patients with the most common mutations - FLT3 internal tandem duplication (ITD) and FLT3 tyrosine kinase domain (TKD) - and would be one of the few advances for the treatment of AML in Europe over the past 40 years.

Gilteritinib received accelerated assessment from the EMA, which allowed the CHMP to reduce the timeframe for approval.

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