FDA approved on September 28 abemaciclib (Verzenio—Eli Lilly) for the treatment of adults who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer that has progressed after taking endocrine therapy. Abemaciclib is approved to be given in combination with an endocrine therapy, called fulvestrant, after the cancer had grown on endocrine therapy. Additionally, it is approved to be given on its own, if patients were previously treated with endocrine therapy and chemotherapy after the cancer had metastasized. "Verzenio provides a new targeted treatment option for certain patients with breast cancer who are not responding to treatment, and unlike other drugs in the class, it can be given as a stand-alone treatment to patients who were previously treated with endocrine therapy and chemotherapy," said Richard Pazdur, MD, director of FDA's Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in FDA's Center for Drug Evaluation and Research. Common adverse effects of abemaciclib include diarrhea, low levels of certain white blood cells, nausea, abdominal pain, infections, fatigue, low levels of red blood cells, decreased appetite, vomiting, and headache. Serious adverse effects include diarrhea, neutropenia, and elevated liver blood tests, and blood clots. Pregnant women should not take abemaciclib because it may cause harm to a developing fetus.