TRANSLATE

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 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.

The AML Hub is an independent medical education platform, sponsored by Astellas, Daiichi Sankyo, Johnson & Johnson, Kura Oncology and Syndax, and has been supported through educational grants from Bristol Myers Squibb and the Hippocrate Conference Institute, an association of the Servier Group. The funders are allowed no direct influence on our content. The levels of sponsorship listed are reflective of the amount of funding given. View funders.

Now you can support HCPs in making informed decisions for their patients

Your contribution helps us continuously deliver expertly curated content to HCPs worldwide. You will also have the opportunity to make a content suggestion for consideration and receive updates on the impact contributions are making to our content.

Find out more

Vyxeos given positive opinion by the EMA CHMP for use in high-risk acute myeloid leukemia patients

By Cynthia Umukoro

Share:

Jul 18, 2018


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.

References