Regulatory approval

Published by the Health Canada. Approved

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.

This is written in the approval document.

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.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

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

Contributions

Date	Contributor	Description
2025-04-10	Van Allen lab	Added propositions and statements for approval of abemaciclib in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for patients with HR+, HER2- breast cancer. Additional propositions are for combinations with letrozole, anastrozole, or exemestane per endocrine offerings within monarchE (NCT03155997).
2024-10-30	Van Allen lab	Initial access of FDA approvals