Jazz Pharma’s leukaemia drug wins EU approval for AML

The European Commission has approved Jazz Pharmaceuticals’ Vyxeos for the treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia or AML with myelodysplasia-related changes. President and COO of Jazz Pharma, Daniel Swisher, said Vyxeos 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. Clinical data from the phase III study demonstrated a superior improvement in overall survival with 9.6 months versus an alternative chemotherapy regimen with 5.9 months.

Professor Charles Craddock CBE, academic director, Centre for Clinical Haematology at University Hospitals Birmingham NHS Foundation Trust, said: “AML is a rare cancer in Europe and patients with therapy-related AML or AML with myelodysplasia-related changes have a particularly poor prognosis compared to people with other forms of leukaemia. Vyxeos is a new and clinically meaningful treatment option that provides a welcome advance for patients and health care professionals across the European Union.”