3 February 2021 - Accelerated approval follows priority review designation and inclusion in overseas new drugs urgently needed in clinical settings.
Astellas Pharma today announced that the China National Medical Products Administration (NMPA) has granted conditional approval to Xospata (gilteritinib) for the treatment of adult patients who have relapsed or refractory acute myeloid leukaemia with a FLT3 mutation detected by a fully validated test.
Gilteritinib has been approved under an expedited pathway, following NMPA's acceptance of gilteritinib for priority review in July 20201 and its inclusion in the third batch of overseas new drugs urgently needed in clinical settings in November 2020.