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FDA approves extended indication of daunorubicin plus cytarabine to include pediatric patients with AML

Apr 1, 2021

On March 30, 2021, the U.S. Food and Drug Administration (FDA) approved an extended indication for CPX-351 (a liposomal formulation of daunorubicin and cytarabine). This means that the label for CPX-351 has been revised to include the treatment of pediatric patients (aged ≥1 year) with newly diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).

Two studies—AAML1421 and CPX-MA-1201—highlighted the promising safety profile of the regimen in pediatric patients and formed the basis of the extended approval. Data from both studies, alongside those conducted in adult patients, suggest that the safety and toxicity profile of CPX-351 do not differ between age groups. 

  1. Jazz Pharmaceuticals plc. Jazz Pharmaceuticals announces FDA approval of additional indication for Vyzeos (daunorubicin and cytarabine) for the treatment of secondary acute myeloid leukemia in pediatric patients. Published March 30, 2021. Accessed March 31, 2021.