Astellas Pharma Inc. said the U.S. Food and Drug Administration accepted the new drug application for the company's blood cancer drug, gilteritinib, and granted it priority review status.
The Japanese drugmaker said the FDA decision is based on the ongoing phase 3 Admiral study evaluating gilteritinib for treating adults with FLT3 mutation-positive acute myeloid leukemia, or AML, that has relapsed or is unresponsive to treatment.
The Prescription Drug User Fee Act target date for an FDA decision is Nov. 29.
AML is a cancer that affects the blood and bone marrow. There are no FLT3-targeting agents approved for treating the disease. About 19,000 new patients will be diagnosed with AML in the U.S. in 2018, according to the American Cancer Society.
The FDA has previously granted both orphan drug designation and fast-track designation to gilteritinib. The drug also received orphan designation from the European Commission. Japan's Ministry of Health, Labour and Welfare granted gilteritinib orphan drug designation and Sakigake designation — similar to the FDA's breakthrough therapy designation.
