Astellas Grabs EC Approval for Acute Myeloid Leukemia Drug

The European Commission has approved Astellas’ Xospata (gilteritinib) as an oral, once-daily therapy to treat adult patients with relapsed or treatment-resistant acute myeloid leukemia.

The commission granted the approval based on results of a phase three clinical trial, which investigated the drug versus salvage chemotherapy in patients with relapsed or refractory AML, in whom Xospata demonstrated significantly longer overall survival than those who received salvage chemotherapy.

The EMA granted the drug orphan designation in January 2018 and approved it following accelerated assessment.