All content on this site is intended for healthcare professionals only. By acknowledging this message and accessing the information on this website you are confirming that you are a Healthcare Professional. If you are a patient or carer, please visit Know AML.

The AML Hub uses cookies on this website. They help us give you the best online experience. By continuing to use our website without changing your cookie settings, you agree to our use of cookies in accordance with our updated Cookie Policy

The AML Hub website uses a third-party service provided by Google that dynamically translates web content. Translations are machine generated, so may not be an exact or complete translation, and the AML Hub cannot guarantee the accuracy of translated content. The AML Hub and its employees will not be liable for any direct, indirect, or consequential damages (even if foreseeable) resulting from use of the Google Translate feature. For further support with Google Translate, visit Google Translate Help.

Steering CommitteeAbout UsNewsletterContact
ALL HubGVhD HubLymphoma HubMDS HubMPN HubMultiple Myeloma

Vyxeos® (CPX-351) granted approval in the EU for the treatment of therapy-related acute myeloid leukemia or AML-MRC

Aug 28, 2018

On 27th August 2018, the European Commission (EC) granted approval to Vyxeos®,  44 mg/100 mg powder for concentrate for solution for infusion for the treatment for the treatment of adults with newly diagnosed, therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC). This comes after the positive opinion recommending a marketing authorization for Vyxeos® was given by the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP).1

The EC approval for Vyxeos®, a liposomal formulation of daunorubicin plus cytarabine co-encapsulated at a molar ratio of 1:5, was based on clinical data from five studies including the pivotal phase III study (NCT01696084), which evaluated the safety and efficacy of Vyxeos® compared to cytarabine and daunorubicin (7+3) in patients with newly diagnosed t-AML and AML-MRC. The results of this pivotal study were recently published by Jeffery Lancet et al. in the Journal of Clinical Oncology.2

Three-hundred and nine patients with newly diagnosed sAML were randomly assigned 1:1 to receive Vyxeos® (n = 153, mean age = 67.8 years) or 7+3 (n = 156, mean age = 67.7) as induction and consolidation chemotherapy. The primary endpoint of the study, overall survival (OS), was met with patients in the Vyxeos® arm significantly had a longer OS compared to patients in the 7+3 arm (Median OS in the Vyxeos® and 7+3 arms: 9.56 vs 5.95 months respectively, HR = 0.69 [95% CI, 0.52–0.90], P = 0.003).2

According to the drug manufacturer’s, Jazz Pharmaceuticals, “Vyxeos® is the first chemotherapy to demonstrate an OS advantage versus the standard of care in a phase III study of older adult patients with newly diagnosed t-AML or AML-MRC”.1

  1. Jazz Pharmaceuticals: Vyxeos® Receives Marketing Authorisation in the European Union for Treatment of Certain Types of High-Risk Acute Myeloid Leukaemia. 2018 Aug 27. [Accessed 2018 Aug 28].
  2. Lancet J. et al. CPX-351 (cytarabine and daunorubicin) Liposome for Injection Versus Conventional Cytarabine Plus Daunorubicin in Older Patients With Newly Diagnosed Secondary Acute Myeloid Leukemia. J Clin Oncol. 2018 Jul 19. DOI: 10.1200/JCO.2017.77.6112. [Epub ahead of print].