Gilteritinib approved in the EU for relapsed or refractory AML patients with a FLT3 mutation
The European Commission have approved once daily Xospata™ (gilteritinib) as a monotherapy for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation.The approval follows gilteritinib receiving orphan designation by the European Medicines Agency, based on results from the Phase III ADMIRAL trial. This trial investigated patients with relapsed or refractory FLT3mut+ AML, receiving gilteritinib versus salvage chemotherapy. Key results include that patients treated with gilteritinib had significantly longer overall survival than those who received salvage chemotherapy. Additionally, the median overall survival for patients who received gilteritinib was 9.3 months, compared to 5.6...