Xospata becomes first and only FLT3 inhibitor approved by China's NMPA

The China National Medical Products Administration (NMPA) has granted conditional approval to Xospata (gilteritinib) for the treatment of adult patients who have relapsed (disease that has returned) or refractory (resistant to treatment) acute myeloid leukemia (AML) with a FLT3 mutation (FLT3mut+) detected by a fully validated test.

Developed by Japan’s Astellas Pharma (TYO: 4503), gilteritinib has been approved under an expedited pathway, following the NMPA’s acceptance of gilteritinib for priority review in July 2020 and its inclusion in the third batch of overseas new drugs urgently needed in clinical settings in November 2020.

“Patients with relapsed or refractory AML with a FLT3 mutation are in urgent need of new treatment options,” said Professor Ma Ju, director of the Harbin Institute of Hematology, China. “As the first approved targeted therapy agent to treat relapsed or refractory AML with a FLT3 mutation in China, gilteritinib, which was approved under an expedited pathway, has enabled patients in China to have rapid access to a novel treatment option,” he added.