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CPX-351 versus 7+3 cytarabine and daunorubicin chemotherapy in older adults with newly diagnosed high-risk or secondary acute myeloid leukaemia: 5-year results of a randomised, open-label, multicentre, phase 3 trial

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Financial Disclosure Statement

JEL has received consulting fees from AbbVie, BerGenBio/DAVA Oncology, Celgene/Bristol Myers Squibb, Daiichi Sankyo, ElevateBio Management, Millennium Pharma/Takeda, and Novartis. GLU has received consulting fees from AbbVie, Agios, GlaxoSmithKline, Jazz Pharmaceuticals, and Novartis, and received honoraria from Astellas Pharma. TLL has received institutional research funding from AbbVie, Aptevo, Astellas Pharma, Bio-Path Holdings, Celgene, Celyad, Genentech/Roche, Gilead Sciences, Incyte, Jazz Pharmaceuticals, Mateon Therapeutics, Ono Pharmaceutical, Pfizer, Prescient Therapeutics, Seattle Genetics, Tolero Pharmaceuticals, and Trovagene. EKR has served as a consultant for Celgene, Incyte, Novartis, and Pfizer; served on speakers bureaus for Ariad Pharmaceuticals, Celgene, Incyte, and Novartis; received research funding from Astellas Pharma, Bristol Myers Squibb, Novartis, NS Pharma, and Pfizer; and received travel support from Celgene and Novartis. RKS has served as a consultant for Sunesis Pharmaceuticals; received honoraria from Sunesis Pharmaceuticals; received research funding from Agios, Astellas Pharma, Bayer AG, Incyte, Jazz Pharmaceuticals, Ono Pharmaceuticals, and Sunesis Pharmaceuticals; and received travel support from Sunesis Pharmaceuticals. SAS has served as a consultant for AbbVie, ArcherDx, Astellas Pharma, Genentech, Incyte, Jazz Pharmaceuticals, Kite Pharma, Kura Oncology, and Novartis; and received research funding from Sunesis Pharmaceuticals. JEK participated in advisory boards for Amgen, Magellan, and Pfizer, and has served on the editorial board for UpToDate. GJS has received research funding from AbbVie, Agios, Actinium, Amgen, Ariad Pharmaceuticals, Astellas Pharma, Bristol Myers Squibb, Constellation, Cyclacel, Daiichi Sankyo, Deciphera, Delta-Fly, Forma, Fujifilm, Gamida, Genentech/Roche, Geron, Incyte, Jazz Pharmaceuticals, Karyopharm, Kite Pharma, Mateon, MedImmune, Novartis, Onconova, Pfizer, Regimmune, Samus, Sangamo, Tolero, and Trovagene; received consulting fees from Agios, Amgen, AstraZeneca, Incyte, Novartis, and Ono Pharma; served on speakers bureaus for Agios, Amgen, Celgene, Gilead Sciences, Incyte, Sanofi, and Stemline; provided expert testimony for Kaiser Permanente; and holds stock ownership and options in Amgen, Bristol Myers Squibb, Johnson & Johnson, and Pfizer. MJW has received research funding from Amgen, Leadiant, Merck, and Shire; participated in advisory committees for Daiichi Sankyo; and holds stock ownership in Reata Pharmaceuticals. DHR holds stock ownership in AbbVie and patents and royalties with the University of Rochester. SF is an employee of and holds stock ownership and options in Jazz Pharmaceuticals. JEC has received consulting fees from Astellas Pharma, Daiichi Sankyo, Jazz Pharmaceuticals, Novartis, and Pfizer; and research funding (to his institution) from Arog, Astellas Pharma, Daiichi Sankyo, Jazz Pharmaceuticals, Novartis, and Pfizer. All other authors declare no competing interests.

Detailed information on funding amounts received by the authors of this publication is available at


VYXEOS® (daunorubicin and cytarabine) liposome for injection 44 mg/100 mg is indicated for the treatment of newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in adults and pediatric patients 1 year and older.



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.

  • VYXEOS is contraindicated in patients with a history of serious hypersensitivity reactions to cytarabine, daunorubicin, or any component of the formulation.
  • Serious or fatal hemorrhage events, including fatal CNS hemorrhages, associated with prolonged severe thrombocytopenia, have occurred in patients treated with VYXEOS. Monitor blood counts regularly and administer platelet transfusion support as required.
  • VYXEOS contains daunorubicin, which has a known risk of cardiotoxicity. Assess cardiac function before, during, and after treatment as clinically indicated. Discontinue in patients with impaired cardiac function unless the benefit of treatment outweighs the risk. VYXEOS treatment is not recommended in patients with cardiac function that is less than normal. Calculate the lifetime cumulative anthracycline exposure prior to each cycle of VYXEOS. VYXEOS is not recommended in patients who have reached the maximum lifetime anthracycline dose limit.
  • If a severe or life-threatening hypersensitivity reaction occurs, discontinue VYXEOS permanently, treat according to the standard of care, and monitor until signs and symptoms resolve.
  • VYXEOS contains copper and has the potential to cause copper overload in patients with Wilson's disease or other copper-related metabolic disorders. Monitor patients and use only if the benefits outweigh the risks. Discontinue in patients with signs or symptoms of acute copper toxicity.
  • Daunorubicin has been associated with severe local tissue necrosis at the site of drug extravasation. Administer VYXEOS by the intravenous route only. Confirm patency of intravenous access before administration.
  • VYXEOS can cause fetal harm. Advise females and males of reproductive potential of the potential risk to a fetus and to use effective contraception.
  • The most common adverse reactions (incidence ≥25%) were hemorrhagic events (74%), febrile neutropenia (70%), rash (56%), edema (55%), nausea (49%), mucositis (48%), diarrhea (48%), constipation (42%), musculoskeletal pain (43%), fatigue (39%), abdominal pain (36%), dyspnea (36%), headache (35%), cough (35%), decreased appetite (33%), arrhythmia (31%), pneumonia (31%), bacteremia (29%), chills (27%), sleep disorders (26%), and vomiting (25%).

Please see full Prescribing Information, including BOXED Warning.

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