FDA approves Lilly’s advanced or metastatic breast cancer therapy

The US Food and Drug Administration (FDA) has approved Verzenio (abemaciclib), from Eli Lilly and Company, for the treatment of adult patients who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer that has progressed after endocrine therapy.

Verzenio works by blocking certain molecules — known as cyclin-dependent kinases 4 and 6 — that promote the growth of cancer cells. The approval includes administration of Verzenio as a combination therapy (with endocrine therapy, fulvestrant) and as a standalone treatment.

“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.

The safety and efficacy of Verzenio both as a standalone therapy and in combination with fulvestrant have been shown in clinical trials, which evaluated 132 and 669 patients respectively.