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Astellas' NDA for Xospata Accepted by NMPA in China

NEW YORK – Astellas Pharma said on Thursday that its new drug application for gilteritinib (Astellas' Xospata) was accepted by China's National Medical Products Administration for regulatory review.

Gilteritinib is intended to treat relapsed or refractory acute myeloid leukemia patients who harbor a FLT3 mutation, a common oncogenic driver of the disease. The drug was approved in 2018 for this setting in the US alongside Invivoscribe Technologies' LeukoStrat CDx companion diagnostic for identifying FLT3 mutations.

Last year, the European Commission also granted approval to gilteritinib based on the clinical outcomes from the Phase III ADMIRAL study, which showed that FLT3-mutated AML patients had an overall survival advantage of four months when treated with the drug.