FDA reviewing Astellas' AML candidate

Astellas Pharma Inc. (Tokyo:4503) said FDA accepted and granted Priority Review to an NDA for gilteritinib to treat relapsed or refractory acute myelogenous leukemia in patients with an FMS-like tyrosine kinase 3 (FLT3; CD135) mutation. The PDUFA date is Nov. 29.

Last week, Astellas announced its 2018 strategic plan, which includes a restructuring of R&D and Japan operations. Part of the strategy includes seeking new drug approvals and expanded labels for key products. Astellas said seeking approval of gilteritinib for several AML indications is a part of that strategy (see BioCentury Extra, May 22)...