Faslodex (fulvestrant) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration. Deprecated

Citation

AstraZeneca UK Limited. Faslodex (fulvestrant) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21344lbl.pdf. Revised April 2002. Accessed October 6, 2026.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication Statements
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. 3

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations
Biomarkers
Cancer types
Therapies
Organizations Biomarkers Cancer types Therapies
FDA (1) ER positive Invasive Breast Carcinoma Fulvestrant
FDA (1) PR positive Invasive Breast Carcinoma Fulvestrant
FDA (1) ER positive, PR positive Invasive Breast Carcinoma Fulvestrant