The China National Medical Products Administration (NMPA) has accepted a New Drug Application (NDA) for gilteritinib (Xospata) for the treatment of adult patients with FLT3
mutation–positive, relapsed/refractory acute myeloid leukemia (AML).1
Moreover, at the interim analysis, the complete remission (CR)/complete remission with partial hematologic recovery (CRh) in the gilteritinib arm was 21% (95% CI, 14.5-28.8).
In the international, phase III ADMIRAL study, 371 adult patients with FLT3-mutant relapsed/refractory AML were randomized 2:1 to receive gilteritinib at 120 mg daily (n = 247) or salvage chemotherapy (n = 124). Patients in both arms then underwent HSCT, but only patients in the gilteritinib arm then resumed treatment with the FLT3 inhibitor; crossover was not permitted. Additionally, salvage chemotherapy was selected prior to randomization and could be one of the following regimens: mitoxantrone, etoposide, and cytarabine; fludarabine, cytarabine, idarubicin, and G-CSF; low-dose cytarabine; and azacitidine.
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