pharmatimesNovember 09, 2018
Jazz Pharmaceuticals’ chemotherapy Vyxeos has won the backing of the National Institute for Health and Care Excellence (NICE) for routine use on the NHS in England and Wales to treat certain acute myeloid leukaemias (AML).
In a Final Appraisal Determination the Institute has approved funding for the drug when used to treat adults with newly diagnosed, therapy-related t-AML or AML with myelodysplasia-related changes (AML-MRC), two types of secondary AML.
"This is the first new chemotherapy in forty years for adults with specific types of newly diagnosed secondary AML, a particularly aggressive cancer that typically affects older people and has a high mortality rate," said Dr Nigel Russell, Professor of Haematology, Faculty of Medicine & Health Sciences at the University of Nottingham.
"I am pleased that NICE has recognised the value of this medicine for adults with secondary AML. In time, it is expected to become the standard of care for this specific group of older AML patients."
Vyxeos is an advanced liposomal formulation that delivers a synergistic molar ratio of daunorubicin and cytarabine, and, according to the firm, is "the first chemotherapy to demonstrate an overall survival advantage versus the standard of care in a Phase III study of older adult patients" with these conditions.
The drug was approved in Europe in August on the back of data from the pivotal Phase III trial, published in the Journal of Clinical Oncology in July, which showed a superior improvement in overall survival compared to an alternative chemotherapy regimen, with 9.6 months versus 5.9 months, respectively.
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