Discussion
AML, anaphylaxis
ANAPHYLAXIS, SEQUELAE, HYPERSENSITIVITY, AML
This study showed that fractionated dosing of GO (3 mg/mAs part of a review of the PK for the prior marketing application of GO, a population PK model was used to simulate exposure for the fractionated GO regimen, based on 8 previous trials in patients with R/R AML or de novo AML [This current study enables comparison of the data from the simulated PK model with clinical PK data. The geometric mean AUC and Safety data were consistent with the known safety profile of the fractionated regimen of GO [In this study, the incidence of ADAs and NAbs was 12% and 2%, respectively. None of the patients experienced anaphylaxis, hypersensitivity, or other clinical sequelae related to ADAs, suggesting that the presence of ADAs to GO did not appear to be associated with any potential safety issues following GO treatment.A best overall response based on CR + CRi was achieved in 9.8% of patients, with a median OS of 2.8 months; both inferior than previously reported in the MyloFrance-1 study [In conclusion, this study showed that the effect of fractionated dosing of GO (3 mg/m