NICE recommends Jazz Pharmaceuticals’ Vyxeos to treat AML

The UK’s National Institute for Health and Care Excellence (NICE) has recommended Jazz Pharmaceuticals’ Vyxeos formulation to treat adults with two types of secondary Acute Myeloid Leukaemia (AML).

Therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) are the two types of secondary AML.

NICE has published a final appraisal determination (FAD) towards this end and recommended Vyxeos 44mg/100mg powder for routine use on the NHS in England and Wales.

Jazz Pharmaceuticals Europe and Rest of World senior vice-president Iain McGill said: "Jazz is delighted that Vyxeos will now be made routinely available on the NHS in England and Wales as people with therapy-related AML or AML with myelodysplasia-related changes have had limited treatment options until now.

"We believe that it is a meaningful medicine for patients with this rapidly progressing and life-threatening blood cancer."

Patients diagnosed with t-AML or AML-MRC have a very poor prognosis and are classified as having the high-risk disease due to these poor outcomes.

The advanced liposomal formulation Vyxeos offers a synergistic molar ratio of daunorubicin and cytarabine.

It is said to be the first chemotherapy to demonstrate a significant overall survival advantage compared to the existing treatment standard, 7+3 chemotherapy, in a Phase III study carried out in older adult patients with newly diagnosed AML types.

The formulation has been developed using the company’s CombiPlex platform, which enables the consideration and design of various treatment combinations.

The European Commission granted Orphan Drug Designation (ODD) to Vyxeos in January 2012. It also received Promising Innovative Medicine (PIM) designation from the Medicines and Healthcare Products Regulatory Agency in the UK.

Last August, it was approved by the European Commission to treat adults with AML in all European Union Member States, in addition to Iceland, Norway and Liechtenstein.