Regulatory approval

Published by the Health Canada. Approved

Health Canada approved everolimus in combination with exemestane for the treatment of postmenopausal women with hormone receptor-positive, HER2-negative advanced breast cancer after recurrence or progression following treatment with letrozole or anastrozole.

This is written in the approval document as:

AFINITOR is indicated for the treatment of postmenopausal women with hormone receptor-positive, HER2-negative advanced breast cancer in combination with exemestane after recurrence or progression following treatment with letrozole or anastrozole.

Citation

Novartis Pharmaceuticals Canada Inc. Afinitor (everolimus) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00063824.PDF. Revised November 2021. 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	Everolimus, Exemestane
HC (1)	HER2-negative, PR positive	Invasive Breast Carcinoma	Everolimus, Exemestane
HC (1)	ER positive, HER2-negative, PR positive	Invasive Breast Carcinoma	Everolimus, Exemestane

Contributions

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