BRIEF—China's regulator accepts Astellas' Xospata for review

Japanese drug major Astellas Pharma’s New Drug Application (NDA) for the oral once-daily therapy 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+), has been accepted by the National Medical Products Administration (NMPA) for regulatory review in China.

Gilteritinib was discovered through a research collaboration with Kotobuki Pharmaceutical, and Astellas has exclusive global rights to develop, manufacture and commercialize gilteritinib.

Gilteritinib was approved in the USA and Japan in 2018, Europe and Canada in 2019, and Korea, Brazil and Australia thus far in 2020 for the treatment of adult patients who have relapsed or refractory FLT3mut+ AML.

As of April 2020, gilteritinib is available in the USA, Japan and selected countries in Europe.