Marking its first regulatory win in the U.S. blood cancer space, Tokyo's Astellas Pharma Inc. has secured approval from the FDA for its oral acute myeloid leukemia (AML) therapy, Xospata (gilteritinib). Already approved in Japan, the FMS-like tyrosine kinase 3 (FLT3) inhibitor is now approved in the U.S. for the treatment of relapsed or refractory AML patients who test positive for the mutation, which is often associated with increased risk of relapse and poor survival.