Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that ER positive status confers therapeutic sensitivity to Fulvestrant in patients with Invasive Breast Carcinoma.
The European Medicines Agency (EMA) has authorized fulvestrant as a monotherapy for the treatment of patients who are postmenopausal women with estrogen receptor positive, locally advanced or metastatic breast cancer. These patients should not have been previously treated with endocrine therapy, or have had disease relapse on or after adjuvant antiestrogen therapy, or disease progression on antiestrogen therapy.
This statement is based on a regulatory approval from the European Medicines Agency:
Faslodex is indicated as monotherapy for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women not previously treated with endocrine therapy, or with disease relapse on or after adjuvant antiestrogen therapy, or disease progression on antiestrogen therapy.