EMA’s advisory group recommends new drug for acute myeloid leukaemia

Gilteritinib (Xospata), a treatment for acute myeloid leukaemia (AML) with a FLT3 mutation, has received a positive opinion recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA). 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 positive/tyrosine kinase domain), and will be one of 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 from 210 to 150 days.