Therapeutic Response

ER positive and HER2-negative status confers therapeutic sensitivity to Letrozole in combination with Ribociclib in patients with Invasive Breast Carcinoma.

Statements

Source and description
Kisqali (ribociclib) [package insert]. FDA. 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.
Kisqali (ribociclib) [product information]. EMA. The European Medicines Agency (EMA) has authorized ribociclib in combination with an aromatase inhibitor or fulvestrant as an initial endocrine-based therapy for the treatment of patients who are women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer, or in women who have received prior endocrine therapy. In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist. This indication is based on three clinical trials: MONALEESA-2, MONALEESA-3, and MONALEESA-7, and MONALEESA-2 evaluated ribociclib in combination with letrozole, an aromatase inhibitor.