FDA approves liposome-encapsulated combination of daunorubicin-cytarabine for adults with AML

Vyxeos represents the first new chemotherapy advance in more than 40 years for these adults with AML.

"Vyxeos is the first new chemotherapy advance in more than 40 years for adults with newly-diagnosed therapy-related AML or AML with myelodysplasia-related changes," said Bruce Cozadd, chairman and CEO of Jazz Pharmaceuticals. "The FDA approval of Vyxeos reflects our commitment to addressing unmet needs within the hematology oncology community."

Designed with Jazz's CombiPlex proprietary technology, Vyxeos is a unique liposomal formulation that delivers a fixed-ratio of daunorubicin and cytarabine to the bone marrow that has been shown to have synergistic effects at killing leukemia cells in vitro and in animal models. Vyxeos is the first product developed with the company's proprietary CombiPlex platform, which enables the design and rapid evaluation of various combinations of therapies.

"Vyxeos is the first chemotherapy to demonstrate an overall survival advantage over the standard of care in a Phase III randomized study of older adults with newly-diagnosed therapy-related AML or AML with myelodysplasia-related changes," said Jeffrey E. Lancet, Chair of the Department of Malignant Hematology at Moffitt Cancer Center. "The prognosis for these patients is poor, so the FDA approval of this new drug provides a welcome therapeutic advance."