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Vyxeos given positive opinion by the EMA CHMP for use in high-risk acute myeloid leukemia patients
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In June 2018, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion recommending marketing authorization for Vyxeos (CPX-351) for the treatment of adults with newly diagnosed, therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC). Vyxeos was approved by the U.S. Food and Drug Administration (FDA) in August 2017.
The marketing authorization application 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 the phase III study showed that CPX-351 improved the survival of older patients with AML.2
CPX-351 is currently being explored in multiple studies in patients with newly diagnosed and relapsed/refractory AML.
- PRNewswire: Vyxeos™ Receives Positive CHMP Opinion for Treatment of Certain Types of High-Risk Acute Myeloid Leukaemia. 2018 Jun 29.https://www.prnewswire.com/news-releases/vyxeos-receives-positive-chmp-opinion-for-treatment-of-certain-types-of-high-risk-acute-myeloid-leukaemia-300674611.html [Accessed 2018 Jul 18].
- Lancet J.E. et al. Final results of phase III randomized trial of CPX-351 versus 7+3 in older patients with newly diagnosed high risk (secondary) AML. Oral Abstract #7000. American Society of Clinical Oncology Meeting 2016.
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