Jazz Pharmaceuticals plc issued the following announcement on Feb. 8.
Jazz Pharmaceuticals plc (Nasdaq: JAZZ) announced that the National Comprehensive Cancer Network® (NCCN®) added Vyxeos™ (daunorubicin and cytarabine) liposome for injection to the Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Myeloid Leukemia (AML).
The United States Food and Drug Administration (FDA) approved Vyxeos on August 3, 2017 for the treatment of adults with two types of AML, a rapidly progressing and life-threatening blood cancer. Vyxeos is the first FDA-approved treatment specifically for adults with newly-diagnosed Therapy-Related AML (t-AML) or AML with Myelodysplasia-Related Changes (AML-MRC). Based on the data from the pivotal Phase 3 randomized trial of Vyxeos versus the standard of care, the NCCN Guidelines now include a Category 1 recommendation for use of Vyxeos for adult patients 60 years of age or greater with newly-diagnosed t-AML or AML-MRC. The Category 1 recommendation indicates that based upon high-level evidence, there is uniform NCCN consensus that Vyxeos is appropriate for these patients.
"We appreciate the decision by the NCCN to incorporate Vyxeos into the Clinical Practice Guidelines in Oncology as it supports our commitment to ensuring that patients, through their health care professionals, are able to access this important new treatment option," said Karen Smith, M.D., Ph.D., executive vice president of research and development and chief medical officer of Jazz Pharmaceuticals. "Vyxeos is the first chemotherapy advance for adults with newly-diagnosed t-AML or AML-MRC in more than 40 years."
The NCCN, a not-for-profit alliance of 27 leading U.S. cancer centers devoted to patient care, research, and education, is dedicated to improving the quality, effectiveness, and efficiency of cancer care. The intent of the NCCN Guidelines is to assist in the decision-making process of individuals involved in cancer care—including physicians, nurses, pharmacists, payers, patients and their families—with the ultimate goal of improving patient care and outcomes.
Original source can be found here.