Astellas has announced the approval of Xospata (gilteritinib) for relapsed (disease that has returned) or refractory (resistant to treatment) acute myeloid leukemia (AML) with a FLT3 mutation by National Medical Products Administration.
AML, most common types of leukemia in adults, impact the blood and bone marrow. The incidence of AML in China is expected to by 80,000 people per year. The average duration of survival is less than six months in patients suffering from AML.
The product has been discovered by a collaboration with Kotobuki Pharmaceutical Co., Ltd. Astellas retain the rights to develop, manufacture, and commercialize gilteritinib. The product has already received the approvals from the drug regulatory authorities of the US and Japan in 2018, Europe and Canada in 2019, Korea, Brazil, and Australia in 2020.
The drug acts by inhibiting LT3- ITD, a type of FLT3mut+, a mutant which is found in one-third of patients suffering from AML.