NICE recommends use of Vyxeos in acute myeloid leukemia.- Jazz Pharma.

The UK National Institute for Health and Care Excellence (NICE) has recommended Vyxeos (daunorubicin and cytarabine), from Jazz Pharma, for routine use on the NHS in England and Wales to treat certain acute myeloid leukaemias (AML). In its Final Appraisal NICE has approved funding for the drug to treat adults with newly diagnosed, therapy-related t-AML or AML with myelodysplasia-related changes (AML-MRC), both of which are forms of secondary AML.

The drug was approved in the EU in August 2018, based on data from five studies, including the pivotal Phase III study. Data from the Phase III study, which met its primary endpoint, were presented at the American Society of Clinical Oncology Annual Meeting in June 2016.

Comment: Patients diagnosed with t-AML or AML-MRC have a very poor prognosis and have the poorest survival of all AML diagnostic subgroups.Thus they are classified as having high risk disease because of these poor outcomes. In the UK , the expected number of these high-risk AML cases is 680 per year. Its incidence increases with age and accounts for approximately 25% of all AML cases in the UK .