CPX-351 (vyxeos) in AML.

Abstract

For decades, the standard induction for patients with acute myeloid leukemia (AML) has been the combination of cytarabine with anthracycline (7 + 3 regimen). In August 2017 the US FDA approved CPX-351 (vyxeos), a liposomal formulation of cytarabine and daunorubicin at a fixed 5:1 molar ratio, for the treatment of adults with newly diagnosed AML with myelodysplasia-related changes (AML-MRC) and therapy-related AML (t-AML). This is the first approved treatment specifically for patients with this subgroup of AML. The approval was based on findings from a multicenter, randomized, open-label, phase III study of CPX-351 Versus 7 + 3 in patients 60-75 years old with newly diagnosed AML-MRC or t-AML. In this study CPX-351 had a higher median OS than 7 + 3 (9.56 vs 5.95 months, HR 0.69; 95% CI: 0.52 to 0.90, p = 0.005). In this profile, we review preclinical and clinical data, and discuss limitations and future directions with CPX-351 use in AML.

• Authors: Mansour Alfayez, Hagop Kantarjian, Tapan Kadia, Farhad Ravandi-Kashani, Naval Daver
• Journal: Leukemia & lymphoma (Leuk Lymphoma) Vol. 61 Issue 2 Pg. 288-297 (02 2020) ISSN: 1029-2403 [Electronic] United States
• PMID: 31547736 (Publication Type: Journal Article, Research Support, N.I.H., Extramural, Research Support, Non-U.S. Gov't, Review)

Chemical References

• CPX-351
• Cytarabine
• Daunorubicin

Topics

• Adult
• Aged
• Antineoplastic Combined Chemotherapy Protocols (adverse effects)
• Cytarabine (therapeutic use)
• Daunorubicin (therapeutic use)
• Humans
• Leukemia, Myeloid, Acute (diagnosis, drug therapy)
• Middle Aged
• Multicenter Studies as Topic
• Myelodysplastic Syndromes (drug therapy)
• Randomized Controlled Trials as Topic