EMA Committee Recommends CPX-351 Approval for 2 AML Types

June 29, 2018 – The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of CPX-351, a fixed-combination of daunorubicin and cytarabine, for adult patients with newly diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC). The recommendation is based on findings from 5 studies, including a pivotal phase III trial. The phase III … (leggi tutto)