VYXEOS is the only FDA-approved treatment for sAML demonstrating superior overall survivala based on a Phase 3 study evaluating the largest sAML population1,2,b
The Phase 3 study was a multicenter, open-label, active-controlled, randomized trial of VYXEOS vs 7+3c in 309 patients (aged 60-75) with newly-diagnosed t-AML or AML-MRC3
VYXEOS was studied in older patients with newly-diagnosed sAML who often face a poor prognosis1,3,7
- De novo AML with MDS-related cytogenetic abnormalities was defined as patients having cytogenetic abnormalities characteristic of myelodysplasia based on 2008 WHO criteria.1,8
View more information about t-AML and AML-MRC
sAML patient characteristics in the Phase 3 study
All patients in the Phase 3 study had difficult-to-treat sAML1,3
41% of patients treated with VYXEOS had prior HMA exposure4
For patients >60 years old with AML, NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend selecting a treatment option based on patient performance status, comorbid conditions, and adverse features such as subtype rather than chronologic age alone10,f
- Includes patients in the prespecified randomization strata of antecedent MDS with prior HMA exposure as well as patients in other strata (eg, therapy-related AML, antecedent CMML) who had previously received HMAs.4
- In the 5-year analysis, 22/138 patients (16%) in the VYXEOS arm and 21/141 patients (15%) in the 7+3 arm had a FLT3 mutation.4
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