In June 2018, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion recommending marketing authorization for Vyxeos (CPX-351) for the treatment of adults with newly diagnosed, therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC). Vyxeos was approved by the U.S. Food and Drug Administration (FDA) in August 2017.
The marketing authorization application for Vyxeos (a liposomal formulation of daunorubicin plus cytarabine co-encapsulated at a molar ratio of 1:5) was based on clinical data from five studies including the pivotal phase III study (NCT01696084), which evaluated the safety and efficacy of Vyxeos compared to cytarabine and daunorubicin (7+3) in patients with newly diagnosed t-AML and AML-MRC. The results of the phase III study showed that CPX-351 improved the survival of older patients with AML.2
CPX-351 is currently being explored in multiple studies in patients with newly diagnosed and relapsed/refractory AML.