Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that ER positive, HER2-negative status confers therapeutic sensitivity to Anastrozole, Ribociclib in patients with Invasive Breast Carcinoma.
The U.S. Food and Drug Administration granted approval to ribociclib in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. This indication is based on MONALEESA-2 (NCT01958021) and MONALEESA-7 (NCT02278120), where either anastrozole or letrozole were chosen for aromatase inhibiton.
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 an aromatase inhibitor as initial endocrine-based therapy.