Astellas AML treatment receives fast track designation from FDA

Astellas Pharma has received fast-track designation in the US for its FLT3 inhibitor, Gilteritinib, a drug that could potentially rival Novartis’ budding $250m-plus product Rydapt (Midostaurin). The FDA gave the status to Gilteritinib as a treatment for adults with FLT3-mutation-positive relapsed or refractory acute myeloid leukaemia (AML), a cancer that impacts blood and bone marrow.

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