FDA approves Lilly’s breast cancer drug Verzenio

SILVER SPRING, Md. — Eli Lilly’s new treatment for certain breast cancers has been approved by the Food and Drug Administration. Verzenio (abemaciclib) was approved to as a treatment for patients with a hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer that is advanced or metastatic and has progressed following endocrine therapy.

"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 standalone treatment to patients who were previously treated with endocrine therapy and chemotherapy," said Dr. Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research.

Verzenio works by blocking certain molecules that are involved in cancer cell growth. It joins two previously approved drugs in this class — palbociclib (Pfizer’s Ibrance) and ribociclib (Novartis’ Kisqali). The National Cancer Institute and the National Institutes of Health estimate that roughly 252,710 people will be diagnosed with breast cancer this year. Approximately 72% of patients have breast cancer with tumors that fit the criteria for treatment with drugs like Verzenio.