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The 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 secondary AML who often face a poor prognosis1,2,4

In the VYXEOS Phase 3 trial, 15% of patients had a FLT3 gene mutation (n=43/279) and 9% had an NPM1 gene mutation (25/283)2

Secondary AML patient characteristics were similar across the treatment arms2

INDICATION

VYXEOS (daunorubicin and cytarabine) liposome for injection 44 mg/100 mg is indicated for the treatment of adults with newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).

IMPORTANT SAFETY INFORMATION

INDICATION

VYXEOS (daunorubicin and cytarabine) liposome for injection 44 mg/100 mg is indicated for the treatment of adults with newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).

Important Safety Information

WARNING: DO NOT INTERCHANGE WITH OTHER DAUNORUBICIN AND/OR CYTARABINE-CONTAINING PRODUCTS

VYXEOS has different dosage recommendations than daunorubicin hydrochloride injection, cytarabine injection, daunorubicin citrate liposome injection, and cytarabine liposome injection. Verify drug name and dose prior to preparation and administration to avoid dosing errors.