Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that ER positive, HER2-negative, PR positive status confers therapeutic sensitivity to Fulvestrant, Ribociclib in patients with Invasive Breast Carcinoma.
The U.S. Food and Drug Administration granted approval to fulvestrant in combination with ribociclib for the treatment of patients who are postmenopausal women with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer, as initial endocrine based therapy or following disease progression on endocrine therapy.
This statement is based on a regulatory approval from the Food and Drug Administration:
KISQALI is a kinase inhibitor indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy.