Regulatory approval

Published by the Health Canada. Approved

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.

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
HC (1)	HER2-negative, PR positive	Invasive Breast Carcinoma	Abemaciclib
HC (1)	ER positive, HER2-negative, PR positive	Invasive Breast Carcinoma	Abemaciclib
HC (1)	ER positive, HER2-negative, PR positive	Invasive Breast Carcinoma	Abemaciclib, Exemestane
HC (1)	ER positive, HER2-negative	Invasive Breast Carcinoma	Abemaciclib, Exemestane
HC (1)	HER2-negative, PR positive	Invasive Breast Carcinoma	Abemaciclib, Exemestane

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals