Gilteritinib accepted for FDA priority review

The US Food and Drug Administration has accepted and granted Priority Review for the New Drug Application (NDA) for gilteritinib.

Japanese drug major Astellas Pharma’s (TYO: 4503) drug is being investigated as a targeted treatment for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a FLT3 mutation, as detected by an FDA-approved test. The news barely moved Astellas’ share price.

Previously, gilteritinib was granted both Orphan Drug designation and Fast Track designation by the US FDA. Gilteritinib also received Orphan Designation from the European Commission (EC) and Orphan Drug Designation from the Japan Ministry of Health, Labor and Welfare (MHLW). The MHLW also granted SAKIGAKE designation to gilteritinib for relapsed/refractory AML.