The European Commission has approved Astellas’ acute myeloid leukemia (AML) drug, Xospata (gilteritinib), following an accelerated assessment and orphan designation by the European Medicines Agency (EMA).
The company has announced that the oral once-daily therapy has been approved by the governing body as a monotherapy for the treatment of adult patients with relapsed or refractory versions of the disorder, and for those with a FLT3 mutation (FLT3mut+).
The approval was based on results from the Phase III ADMIRAL trial, which investigated Xospata and found that the study arm treated with the drug had significantly longer overall survival (OS) than those who received salvage chemotherapy, as well as a median overall survival of 9.3 months, compared to 5.6 months for salvage chemotherapy.
One-year survival rates also shot to 37% for patients who received Xospata, compared to 17% for patients who received salvage chemotherapy.
The approval marks a “significant advance for patients living with relapsed or refractory, FLT3 mutation-positive acute myeloid leukemia,” said Andrew Krivoshik, senior vice president and global therapeutic area head, oncology development, Astellas.
He continued, “We look forward to working with health authorities across the EU to bring Xospata to patients who need it the most, as soon as possible.”
AML is a type of cancer in which the bone marrow makes abnormal myeloblasts - a type of white blood cell - red blood cells, or platelets, and usually gets worse quickly if it is not treated.