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

Aug 28, 2018

On 27 th 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 recentlypublished 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 versusthe 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].