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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.

Citation:

FDA approves new treatment for certain advanced or metastatic breast cancers [news release]. Silver Spring, MD: FDA. September 28, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm578071.htm. Accessed October 1, 2017.

Verzenio [package insert]. Indianapolis, IN: Eli Lilly and Company. 2017. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/208716s000lbl.pdf. Accessed October 1, 2017.

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