Vyxeos is the first product designed with the Dublin-based company’s CombiPlex technology, delivering a fixed-ratio of daunorubicin and cytarabine to a patient’s bone marrow.
“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,” chairman & CEO Bruce Cozadd said in prepared remarks. “The FDA approval of Vyxeos reflects our commitment to addressing unmet needs within the hematology oncology community.”
“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,” Dr. Jeffrey Lancet, chair of the dept. of malignant hematology at Moffitt Cancer Center, added. “The prognosis for these patients is poor, so the FDA approval of this new drug provides a welcome therapeutic advance.”