Clinical Edge

Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions

Verzenio Approved for Certain Breast Cancers

FDA news release; 2017 Sep 28

The FDA has approved Verzenio (abemaciclib) to treat adult patients who have hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.

Indications: Verzenio is a kinase inhibitor indicated either with or without fulvestrant for the treatment of women with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.

Dosage and administration: 150 mg twice daily in combination with fulvestrant, or 200 mg twice daily as monotherapy.

Efficacy and safety: Approval is based on results from 2 trials showing that 1) Verzenio produced better progression-free survival than placebo when combined with fulvestrant, and 2) 2 in every 10 patients taking it as monotherapy experienced complete or partial tumor shrinkage.

Side effects/risks: The most common adverse reactions are diarrhea, neutropenia, nausea, abdominal pain, infections, fatigue, anemia, leukopenia, decreased appetite, vomiting, headache, and thrombocytopenia.


FDA approves new treatment for certain advanced or metastatic breast cancers [news release]. Silver Spring, MD: FDA. September 28, 2017. Accessed October 1, 2017.

Verzenio [package insert]. Indianapolis, IN: Eli Lilly and Company. 2017. Accessed October 1, 2017.

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Verzenio Approved for Certain Breast Cancers, FDA news release; 2017 Sep 28

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FDA Approves New Mammography System, FDA news release; 2017 Sep 1

Cochrane Evaluates Survivorship Programs for BC, Cochrane; 2017 Aug 24; Cheng KKin Fong, et al