Verzenio Approved for Advanced Breast Cancer

Verzenio (abemaciclib) has been approved by the U.S. Food and Drug Administration to treat women with certain advanced forms of breast cancer, the most common cancer in the United States.

More than 250,000 women are projected to be diagnosed with breast cancer this year, and more than 40,000 will die of the disease, the U.S. National Cancer Institute estimates.

Verzenio is designed to block substances called cyclin-dependent kinases that are thought to spur the growth of cancer cells. The drug is approved for hormone receptor-positive and HER2-negative forms of advanced or spreading breast cancer that have been treated with a therapy that changes a person's hormones (endocrine therapy).

"Verzenio provides a new targeted treatment option for certain patients with breast cancer who are not responding to treatment, and unlike [similar drugs], 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.

The drug was evaluated in clinical studies involving almost 700 people whose breast cancer had progressed after treatment with endocrine therapy. The average time of progression-free survival for people taking Verzenio was 16.4 months, compared with 9.3 months among those who took a placebo, the FDA said.

The most common side effects included diarrhea, low white-blood-cell count, nausea and vomiting, abdominal pain, infection, fatigue, anemia, loss of appetite and headache. More serious adverse reactions could include elevated liver enzymes and blood clots, the agency said.

Verzenio is produced by Eli Lilly, based in Indianapolis.

More information

Visit the FDA to learn more.


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