On September 28, 2017, the FDA approved Verzenio (abemaciclib; from Eli Lilly), a CDK4/CDK6 inhibitor, in combination with fulvestrant, for the treatment of women with HR-positive, HER2-negative advanced or metastatic breast cancer that progressed after endocrine therapy, as well as for use alone in patients whose metastatic breast cancer progressed after endocrine therapy and after previous use of chemotherapy in the metastatic setting.
“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 the FDA’s Oncology Center of Excellence.
The FDA approved Verzenio for these 2 uses based on clinical trials showing its benefits for patients with HR-positive, HER2-negative advanced or metastatic breast cancer. The most common side effects with Verzenio are diarrhea, neutropenia, nausea, abdominal pain, infections, fatigue, anemia, leukopenia, decreased appetite, vomiting, headache, and thrombocytopenia.
