CHMP recommends approval of Vyxeos in acute myeloid leukaemia or AML with myelodysplasia-related changes.- Jazz Pharma.

Jazz Pharmaceuticals announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending marketing authorisation of Vyxeos (cytarabine daunorubicin) 44 mg/100 mg powder for concentrate for solution for infusion for the treatment of adults with newly diagnosed, therapy-related acute myeloid leukaemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC). Vyxeos is an advanced liposomal formulation that delivers a fixed-ratio (1:5) of daunorubicin and cytarabine.

The Marketing Authorisation Application (MAA) for Vyxeos includes clinical data from five studies, including the pivotal Phase 3 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. Jazz Pharmaceuticals filed a MAA for Vyxeos in November 2017 after the CHMP granted accelerated assessment.