CPX-351 Approved in Europe for 2 AML Types

August 27, 2018 – The European Commission has approved 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 approval is based on findings from 5 studies, including a pivotal phase III trial. The phase III study compared CPX-351 with traditional cytarabine and daunorubicin (7+3) for patients with newly … (leggi tutto)