On April 17, Astellas’ marketing application for gilteritinib fumarate tablets submitted in China was proposed for inclusion in the priority review program under Category I(3) of the Priority Review Scope, which covers innovative drugs with significant therapeutic advantages.
Gilteritinib is an FMS-like tyrosine kinase 3 (FLT3) inhibitor co-developed by Astellas and Kotobuki Pharmaceutical, which inhibits FLT3 mutations. The drug was approved for marketing in Japan and the United States in 2018 for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) harboring FLT3 mutations, becoming the first FLT3 inhibitor approved by the FDA for relapsed or refractory AML.
Astellas’ marketing authorization application for gilteritinib in China was accepted by the Center for Drug Evaluation (CDE) on April 11, for the treatment of adult patients with relapsed or refractory (treatment-resistant) acute myeloid leukemia (AML) harboring FLT3 mutations.
Acute myeloid leukemia is a cancer that affects the blood and bone marrow, with its incidence increasing with age. It is estimated that approximately 80,000 people in China are diagnosed with leukemia each year. Acute myeloid leukemia is one of the most common types of leukemia in adults.
Patients with FLT3 mutation-positive acute myeloid leukemia (AML) have a very poor prognosis, with a median survival of less than 6 months following salvage chemotherapy. During the course of AML treatment, and even after relapse, the FLT3 mutation status may change. Therefore, confirming the patient’s FLT3 mutation status helps determine the optimal treatment approach.