Regulatory approval

Published by the Health Canada. Approved

Health Canada approved fulvestrant for the treatment of estrogen receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy.

This is written in the approval document as:

FASLODEX (fulvestrant) is indicated for the treatment of estrogen receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy.

Citation

AstraZeneca Canada Inc. Faslodex (fulvestrant) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00053975.PDF. Revised November 2019. 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	Fulvestrant

Contributions

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