Astellas Announces NMPA Acceptance of New Drug Application for Gilteritinib for Relapsed/Refractory FLT3-Mutated Acute Myeloid Leukemia in China

Astellas Pharma Group Announces Today That the China National Medical Products Administration (NMPA) Has Accepted XOSPATA^® New Drug Application (NDA) for once-daily oral gilteritinib for the treatment of adult patients with relapsed or refractory (treatment-resistant) FLT3 mutation-positive (FLT3mut+) acute myeloid leukemia (AML).

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 after 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.

Gilteritinib is a FMS-like tyrosine kinase 3 (FLT3) inhibitor that acts against two common FLT3 mutations—FLT3-ITD and FLT3-TKD—found in approximately one-third of patients with acute myeloid leukemia. FLT3-ITD is a common driver mutation associated with high disease burden and poor prognosis.