Jazz Pharmaceuticals Plc said the U.S. Food and Drug Administration approved Vyxeos liposome for injection to treat adults with two types of acute myeloid leukemia.
The drug, which combines daunorubicin and cytarabine, is approved to treat patients with newly diagnosed therapy-related acute myeloid leukemia or acute myeloid leukemia with myelodysplasia-related changes.
FDA granted the approval based on the results of a phase 3 trial where patients who received Vyxeos lived longer with a 9.6 months median overall survival, versus the 5.9 months of those who were separately given cytarabine and daunorubicin.
The drug previously received priority review, breakthrough therapy and fast track designations from the FDA. It was also assigned orphan drug status by the FDA and the European Commission to treat acute myeloid leukemia.