The Scottish Medicines Consortium (SMC) has accepted the use of Jazz Pharmaceuticals’ Vyxeos® (daunorubicin and cytarabine) 44 mg/100 mg powder for concentrate for solution for infusion within the NHS in Scotland for the treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).
Outcomes for these patients are historically poor, meaning that they are recognised as having high-risk AML.
AML is a rare form of blood cancer that is particularly difficult to treat. People with high-risk AML have a very poor prognosis; less than 6% survive five years after being diagnosed.
In Scotland, there are approximately 45 new cases of t-AML and AML MRC each year, a number that is expected to rise as the population ages. Due to the seriousness of these forms of cancer, only a small minority of patients are expected to be fit enough to receive Vyxeos.
Vyxeos is an advanced liposomal formulation that delivers a synergistic molar ratio of daunorubicin and cytarabine to the bone marrow. It is the first chemotherapy to demonstrate a significant overall survival benefit versus 7+3 chemotherapy in a Phase 3 study of older patients with t-AML or AML-MRC, and the first treatment option specifically for people who have these types of high-risk AML.
Dr Mark Drummond, Consultant Haematologist at the Beatson Cancer Centre, Glasgow, called the SMC’s acceptance of this treatment “an important milestone for patients who have been diagnosed with t-AML or AML-MRC in Scotland”.
“It is the first new chemotherapy in four decades for these types of high-risk AML that has demonstrated an improved overall survival when compared to a standard of care regimen,” he said. “There has been a real need for new, effective treatment options as response rates to current therapies are substantially lower than those for other types of AML.”
Zack Pemberton-Whiteley, Patient Advocacy Director at Leukaemia Care, said: “The SMC’s announcement is a really positive development for t-AML or AML-MRC patients in Scotland, helping families gain more precious time with their loved ones.”
Dr Kelvin Tan, General Manager, UK and Ireland at Jazz Pharmaceuticals, said: “Jazz welcomes the SMC’s decision to make Vyxeos routinely available on the NHS in Scotland to treat t-AML and AML-MRC.”