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Xospata Conditionally Approved in China for Certain Acute Myeloid Leukemias

Xospata (gilteritinib) has been conditionally approved in China to treat adults who have relapsed or refractory acute myeloid leukemia (AML) with mutations in the FLT3 gene. The therapy’s conditional approval by the Chinese National Medical Products Administration (NMPA) followed an expedited regulatory pathway, as the therapy was previously granted priority review and added to the NMPA’s list of new treatments from overseas that are urgently needed in a clinical setting. With this approval, Xospata has…