The ADMIRAL trial found that gilteritinib is a significant addition to the treatments available for patients with FLT3 mutation-positive relapsed or refractory acute myeloid leukemia.
Gilteritinib (Xospata, Astellas Pharma) demonstrated significantly longer overall survival (OS) than salvage chemotherapy in adult patients with relapsed or refractory acute myeloid leukemia (AML) with an FMS-like tyrosine kinase 3 (FTL3) mutation in a recent study. The results were based off of the phase 3 ADMIRAL trial, published in The New England Journal of Medicine.
The ADMIRAL trial was an open-label, multicenter, randomized study that included approximately 371 patients with relapsed or refractory AML and positive for FLT3 mutations present in bone marrow or whole blood as determined by the central lab from 140 centers in North America, Europe and Asia. Participants were randomized 2:1 to receive either gilteritinib or salvage chemotherapy.
Participants in the gilteritinib group received 120 mg dose orally once a day in continuous 28-day cycles. The treatment continued until participants met 1 of the treatment discontinuation criteria.
Participants on salvage chemotherapy received intravenous (IV) mitoxantrone 8 mg/m^2 daily for 5 days, etoposide 100 mg/m^2 daily by IV for 5 days, and cytarabine 1000 mg/m^2 daily by IV for 5 days (days 1-5).
The findings from the ADMIRAL trial have found that gilteritinib is a significant addition to the treatments available for patients with FLT3 mutation-positive relapsed or refractory AML. Common adverse events from the study of grade 3 or higher in the gilteritinib group were febrile neutropenia (45.9%), anemia (40.7%), and thrombocytopenia (22.8%).
The FDA approved a supplemental New Drug Application (sNDA) in May 2019 to update the US product labeling for gilteritinib to include final analysis OS data from the ADMIRAL trial.