The initial FDA approval of VYXEOS (CPX-351) was based on data from a large, pivotal, Phase 3 study1
The Phase 3 study was a multicenter, open-label, active-controlled, randomized trial of VYXEOS vs 7+3a in 309 patients (aged 60-75) with newly-diagnosed t-AML or AML-MRC2
VYXEOS was studied in older patients with newly-diagnosed sAML who often face a poor prognosis1,2,6
- De novo AML with MDS-related cytogenetic abnormalities was defined as patients having cytogenetic abnormalities characteristic of myelodysplasia based on 2008 WHO criteria.1,7
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 sAML1,2
41% of patients treated with VYXEOS had prior HMA exposure1
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 alone9,f
- Includes patients in the prespecified randomization strata of antecedent MDS with prior HMA exposure as well as patients in other strata (eg, t-AML, antecedent CMML) who had previously received HMAs.1
- 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.3
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