Verzenio (abemaciclib) [product monograph]. HC.

Regulatory approval published by the Health Canada.

Citation

Eli Lilly Canada Inc. Verzenio (abemaciclib) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00073683.PDF. Revised December 2023. Accessed June 2025.

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Regulatory approvals

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

Indication Statements
VERZENIO (abemaciclib) is indicated in combination with endocrine therapy 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 disease recurrence based on clinicopathological features. 3
VERZENIO (abemaciclib) is indicated for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor in postmenopausal women as initial endocrine-based therapy, in combination with fulvestrant in women with disease progression following endocrine therapy, or as a single agent in women with disease progression following endocrine therapy and at least 2 prior chemotherapy regimens. 6

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type Biomarker(s) Cancer type Therapy(ies)
Sensitivity (+) ER positive, HER2-negative Invasive Breast Carcinoma Abemaciclib, Tamoxifen
Sensitivity (+) HER2-negative, PR positive Invasive Breast Carcinoma Abemaciclib, Tamoxifen
Sensitivity (+) ER positive, HER2-negative, PR positive Invasive Breast Carcinoma Abemaciclib, Tamoxifen
Sensitivity (+) ER positive, HER2-negative Invasive Breast Carcinoma Abemaciclib
Sensitivity (+) HER2-negative, PR positive Invasive Breast Carcinoma Abemaciclib
Sensitivity (+) ER positive, HER2-negative, PR positive Invasive Breast Carcinoma Abemaciclib
Sensitivity (+) ER positive, HER2-negative, PR positive Invasive Breast Carcinoma Abemaciclib, Exemestane
Sensitivity (+) ER positive, HER2-negative Invasive Breast Carcinoma Abemaciclib, Exemestane
Sensitivity (+) HER2-negative, PR positive Invasive Breast Carcinoma Abemaciclib, Exemestane