Jazz announced that the Food and Drug Administration (FDA) has approved Vyxeos (daunorubicin and cytarabine) liposome for injection to treat adults with newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC).
The approval was supported by data from a study in 309 patients (60–75 years of age) with newly diagnosed t-AML or AML-MRC who were randomized to either Vyxeos or cytarabine and daunorubicin separately. The data showed patients treated with Vyxeos had longer overall survival vs. patients who received separate treatments of cytarabine and daunorubicin (median 9.56 months vs. 5.95 months).
Hemorrhage, febrile neutropenia, rash, edema, nausea, mucositis, diarrhea, among others, were reported as common adverse effects of Vyxeos. The drug carries a Boxed Warning stating it is not interchangeable with other daunorubicin- or cytarabine-containing products.
Vyxeos utilizes the proprietary CombiPlex technology, which uses liposomes to control the release and distribution of amphipathic drugs, and nanoparticles to control the release and distribution of hydrophobic drugs. The resulting liposomal formulation provides a fixed-ratio of daunorubicin, an anthracycline topoisomerase inhibitor, and cytarabine, a nucleoside metabolic inhibitor, to the bone marrow. Both in vitro and animal models have demonstrated their synergistic effects at killing leukemia cells.
“Vyxeos is the first chemotherapy to demonstrate an overall survival advantage over the standard of care in a Phase 3 randomized study of older adults with newly-diagnosed therapy-related AML or AML with myelodysplasia-related changes,” said Jeffrey E. Lancet, MD, from the Moffitt Cancer Center.
Vyxeos injection will be available as a 44mg/100mg strength lyophilized cake in single-dose vials in 2- and 5-count cartons. It was previously granted Priority Review status, as well as Breakthrough Therapy, Orphan Drug, and Fast Track designations by the FDA. Vyxeos is anticipated to be available within one week.
For more information call (800) 520-5568 or visit Vyxeos.com.