Xospata cleared by EC as monotherapy for AML

The European Commission (EC) has approved the oral once-daily therapy Xospata (gilteritinib) as a monotherapy for the treatment of adult patients with relapsed or refractory (resistant to treatment) acute myeloid leukemia (AML) with a FLT3 mutation (FLT3mut+), Japanese drug major Astellas Pharma (TYO: 4503) announced this morning.

This is a boost for Astellas, which means it is now ahead of Japan’s Daiichi Sankyo (TYO: 4568), which just last week gained a negative opinion from the European Medicines Agency’s advisory committee for its rival candidate Vanflyta (quizartinib) which was expected to be used to treat adults with acute myeloid leukemia (a cancer of the white blood cells). In June, it also received a Complete Response Letter (CRL) from the US Food and Drug Administration.

Gilteritinib has the potential to improve treatment outcomes for AML patients with two forms of the most common mutation—FLT3 internal tandem duplication (ITD) and FLT3 tyrosine kinase domain (TKD) mutation.