Verzenio (abemaciclib) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration.

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 30, 2024.

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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
Verzenio is a kinase inhibitor indicated in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. 6
Verzenio is a kinase inhibitor indicated 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. 3
Verzenio is a kinase inhibitor indicated 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. 3

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organization(s) Biomarker(s) Cancer type Therapy(ies)
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 (2) ER positive, HER2-negative Invasive Breast Carcinoma Abemaciclib, Anastrozole
FDA (2) HER2-negative, PR positive Invasive Breast Carcinoma Abemaciclib, Anastrozole
FDA (2) ER positive, HER2-negative, PR positive Invasive Breast Carcinoma Abemaciclib, Anastrozole
FDA (2) ER positive, HER2-negative Invasive Breast Carcinoma Abemaciclib, Letrozole
FDA (2) HER2-negative, PR positive Invasive Breast Carcinoma Abemaciclib, Letrozole
FDA (2) ER positive, HER2-negative, PR positive Invasive Breast Carcinoma Abemaciclib, Letrozole
FDA (1) ER positive, HER2-negative Invasive Breast Carcinoma Abemaciclib, Fulvestrant
FDA (1) HER2-negative, PR positive Invasive Breast Carcinoma Abemaciclib, Fulvestrant
FDA (1) ER positive, HER2-negative, PR positive Invasive Breast Carcinoma Abemaciclib, Fulvestrant
FDA (1) ER positive, HER2-negative Invasive Breast Carcinoma Abemaciclib
FDA (1) HER2-negative, PR positive Invasive Breast Carcinoma Abemaciclib
FDA (1) ER positive, HER2-negative, PR positive Invasive Breast Carcinoma Abemaciclib
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