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Verzenio FDA Approval History

Last updated by Judith Stewart, BPharm on Nov 10, 2021.

FDA Approved: Yes (First approved September 28, 2017)
Brand name: Verzenio
Generic name: abemaciclib
Dosage form: Tablets
Company: Eli Lilly and Company
Treatment for: Breast Cancer

Verzenio (abemaciclib) is a selective ATP-competitive inhibitor of cyclin dependent kinases (CDK) 4 and 6 used for the treatment of patients with hormone receptor-positive, human epidermal growth factor receptor 2 negative (HR+ HER2-) metastatic breast cancer.

  • Approximately 70 percent of all breast cancers are of the HR+ HER2- subtype.
  • Verzenio works inside the cell to block CDK4/6 activity and help stop the growth of cancer cells.
  • Verzenio is indicated:
    • in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence and a Ki 67 score ≥20% as determined by an FDA approved test.
    • in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer.
    • in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.
    • as monotherapy for the treatment of adult patients with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy and prior chemotherapy in the metastatic setting.
  • Verzenio tablets are usually taken orally twice daily with or without food.
  • Verzenio can cause serious adverse reactions including severe diarrhea, neutropenia, interstitial lung disease (ILD)/pneumonitis, hepatotoxicity, and venous thromboembolism.
  • Common adverse reactions include diarrhea, neutropenia, nausea, abdominal pain, infections, fatigue, anemia, leukopenia, decreased appetite, vomiting, headache, alopecia, and thrombocytopenia.

Development Timeline for Verzenio

DateArticle
Oct 13, 2021Approval  FDA Approves Verzenio (abemaciclib) as the First and Only CDK4/6 Inhibitor for Certain People with HR+ HER2- High Risk Early Breast Cancer
Feb 26, 2018Approval  Lilly Receives Additional FDA Approval for Verzenio (abemaciclib), as Initial Treatment for Advanced Breast Cancer
Sep 28, 2017Approval  FDA Approves Verzenio (abemaciclib) for Certain Advanced or Metastatic Breast Cancers
Jul 12, 2017FDA Grants Priority Review for Lilly's Abemaciclib for the Treatment of Advanced Breast Cancer
Jun  3, 2017Lilly Builds Upon Body Of Data For Abemaciclib With Phase 3 MONARCH 2 Data Demonstrating Superior Progression-Free Survival In Advanced Breast Cancer

Further information

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