The U.S. Food and Drug Administration granted fast-track designation to Astellas Pharma Inc.'s gilteritinib to treat a certain type of blood cancer.
The designation covers the company's study of gilteritinib in adult patients with FLT3+ relapsed or refractory acute myeloid leukemia.
Astellas Pharma said four phase 3 trials of gilteritinib in various AML patient populations are underway.
Gilteritinib is an investigational compound discovered through a research collaboration between Astellas Pharma and Kotobuki Pharmaceutical Co. Ltd.
Astellas has exclusive global rights to the drug.