Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that ER positive, HER2-negative 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, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer not previously treated with 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 hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer in postmenopausal women not previously treated with endocrine therapy.