Japan's Astellas Pharma Inc. said the European Commission gave market approval to its blood cancer treatment Xospata, over a month after the regulator issued a positive opinion on the drug.
Xospata, or gilteritinib, was developed as a single therapy to treat adult patients whose acute myeloid leukemia with the FLT3 mutation has either returned or is unresponsive to treatment.
Acute myeloid leukemia is a type of fast-growing cancer in which too many immature white blood cells, known as myeloblasts, are found in the bone marrow and blood.
The EU approval is based on the results of a late-stage study, dubbed Admiral, in which patients who were given Xospata showed significantly higher average overall survival as compared to those given chemotherapy.
The drug received an accelerated assessment from the European Medicines Agency in February, resulting in the reduced time frame for the therapy's approval.
Xospata is also approved in the U.S. and Japan to treat adult patients with the same disorder.