CHMP recommends aproval of Xospata in FLT3+ acute myeloid leukemia.- Astellas Pharma

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

The CHMP decision is based on results from the Phase III ADMIRAL trial, which investigated gilteritinib versus salvage chemotherapy in patients with relapsed or refractory FLT3mut+ AML. Patients treated with gilteritinib had significantly longer OS than those who received salvage chemotherapy. Median OS for patients who received gilteritinib was 9.3 months, compared to 5.6 months for patients who received salvage chemotherapy (Hazard Ratio = 0.64 (95% CI 0.49, 0.83), P=0.0004). Rates of one-year survival were 37% for patients who received gilteritinib, compared to 17% for patients who received salvage chemotherapy.

Comment: In late 2018, gilteritinib was approved by regulatory agencies in the U.S. and Japan for the treatment of adult patients who have relapsed or refractory FLT3mut+ AML.