Verzenio (abemaciclib) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration. Deprecated

Citation

Eli and Lily Company. Verzenio (abemaciclib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/208716s010s011lbl.pdf. Revised March 2023. Accessed October 6, 2026.

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Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication Statements
Verzenio is a kinase inhibitor 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. 12

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations
Biomarkers
Cancer types
Therapies
Organizations Biomarkers Cancer types Therapies
FDA (1) ER positive, HER2-negative Invasive Breast Carcinoma Abemaciclib, Tamoxifen
FDA (1) HER2-negative, PR positive Invasive Breast Carcinoma Abemaciclib, Tamoxifen
FDA (1) ER positive, HER2-negative, PR positive Invasive Breast Carcinoma Abemaciclib, Tamoxifen
FDA (1) ER positive, HER2-negative Invasive Breast Carcinoma Abemaciclib, Anastrozole
FDA (1) HER2-negative, PR positive Invasive Breast Carcinoma Abemaciclib, Anastrozole
FDA (1) ER positive, HER2-negative, PR positive Invasive Breast Carcinoma Abemaciclib, Anastrozole
FDA (1) ER positive, HER2-negative Invasive Breast Carcinoma Abemaciclib, Letrozole
FDA (1) HER2-negative, PR positive Invasive Breast Carcinoma Abemaciclib, Letrozole
FDA (1) ER positive, HER2-negative, PR positive Invasive Breast Carcinoma Abemaciclib, Letrozole
FDA (1) ER positive, HER2-negative, PR positive Invasive Breast Carcinoma Abemaciclib, Exemestane
FDA (1) ER positive, HER2-negative Invasive Breast Carcinoma Abemaciclib, Exemestane
FDA (1) HER2-negative, PR positive Invasive Breast Carcinoma Abemaciclib, Exemestane