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CPX-351 Approved in Europe for 2 AML Types

Jason M. Broderick @jasoncology
Published: Monday, Aug 27, 2018

Charles Craddock, CBE, FRCP, FRCPath, DPhil

Charles Craddock, CBE, FRCP, FRCPath, DPhil

The European Commission has approved CPX-351 (Vyxeos), a fixed-combination of daunorubicin and cytarabine, for adult patients with newly diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).

In the United States, the FDA approved CPX-351 in August 2017 for adult patients with newly diagnosed t-AML or AML-MRC. The approval came with a boxed warning advising against interchanging the medication with other daunorubicin- and/or cytarabine-containing products. The FDA also advised against using CPX-351 in patients with a history of serious hypersensitivity to daunorubicin, cytarabine, or any component of the formulation.
Lancet JE, Uy GL, Cortes JE, et al. Final results of a phase III randomized trial of CPX-351 versus 7+3 in older patients with newly diagnosed high risk (secondary) AML. J Clin Oncol. 34, 2016 (suppl; abstr 7000).

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