Regulatory approval

Published by the Food and Drug Administration. Approved

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

This is written in the approval document.

Citation

AstraZeneca UK Limited. Faslodex (fulvestrant) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021344s044lbl.pdf. Revised January 2021. Accessed October 30, 2024.

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	ER positive, HER2-negative	Invasive Breast Carcinoma	Fulvestrant
FDA (2)	HER2-negative, PR positive	Invasive Breast Carcinoma	Fulvestrant
FDA (2)	ER positive, HER2-negative, PR positive	Invasive Breast Carcinoma	Fulvestrant

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2017-08-25	Food and Drug Administration	Indication received traditional approval.