Therapeutic Response Statement (Sensitivity)

This therapeutic response statement supports the relationship that ER positive, PR positive status confers therapeutic sensitivity to Fulvestrant in patients with Invasive Breast Carcinoma.

The U.S. Food and Drug Administration granted approval to fulvestrant for the treatment of patients who are postmenopausal women with hormone receptor (HR)-positive advanced breast cancer with disease progression following endocrine therapy.

This statement is based on a regulatory approval from the Food and Drug Administration:

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.

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.