European Commission approves Vyxeos to treat acute myeloid leukaemia patients.- Jazz Pharma
Jazz Pharmaceuticals plc announced that the European Commission approved Vyxeos 44 mg/100 mg powder (cytarabine daunorubicin) 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 synergistic molar ratio of daunorubicin and cytarabine.
"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 newly diagnosed therapy- related AML or AML with myelodysplasia-related changes," said Daniel Swisher , president and chief operating officer at Jazz Pharmaceuticals.
The European Commission approval extends to all European Union Member States, as well as Iceland , Norway and Liechtenstein.
Comment: Analysts consider that Vyxeos will become the standard of care for newly diagnosed elderly patients with secondary AML, but price will be a crucial factor in determining uptake.
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