The U.S. Food and Drug Administration today approved abemaciclib (Verzenio) to treat adult patients who have hormone receptor–positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer that has progressed after endocrine therapy. Abemaciclib is...
The FDA Drug Information Soundcast in Clinical Oncology (DISCO) is a new podcast series from the U.S. Food and Drug Administration’s (FDA) Oncology Center of Excellence (OCE), covering new product approvals, emerging safety information for cancer treatments, and other current topics in cancer ...
Today, the U.S. Food and Drug Administration (FDA) Commissioner Robert Califf, MD, issued the following statement: “Today the U.S. Food and Drug Administration is establishing the Oncology Center of Excellence (OCE) and appointing Richard Pazdur, MD, as its Director. This will make...
The U.S. Food and Drug Administration (FDA) today approved uridine triacetate (Vistogard) for the emergency treatment of adults and children who receive an overdose of the cancer treatment fluorouracil (5-FU) or capecitabine, or who develop certain severe or life-threatening toxicities within...
On October 21 in Washington, DC, the National Coalition for Cancer Survivorship (NCCS) hosted a reception to honor Richard Pazdur, MD, and Ellen Goodman. Special guest Robert M. Califf, MD, Deputy Commissioner for Medical Products and Tobacco at the U.S. Food and Drug Administration (FDA),...
The U.S. Food and Drug Administration (FDA) today expanded the approved use of denosumab (Xgeva) to treat adults and some adolescents with giant cell tumor of the bone, a rare and usually noncancerous tumor. Denosumab, which was granted orphan product designation, was reviewed under the FDA’s ...