Regulatory approval

Published by the Food and Drug Administration. Approved

FASLODEX is an estrogen receptor antagonist indicated for the treatment of HR-positive advanced breast cancer in postmenopausal women with disease progression following 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	Invasive Breast Carcinoma	Fulvestrant
FDA (2)	PR positive	Invasive Breast Carcinoma	Fulvestrant
FDA (2)	ER positive, PR positive	Invasive Breast Carcinoma	Fulvestrant

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals
2002-04-25	Food and Drug Administration	Indication received traditional approval.