Therapeutic Response

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

Statements

Source and description
Faslodex (fulvestrant) [package insert]. FDA. 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.
Kisqali (ribociclib) [package insert]. FDA. The U.S. Food and Drug Administration granted approval to ribociclib in combination with fulvestrant for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer as either an initial endocrine-based therapy or following disease progression on endocrine therapy.
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.
Ribociclib Therapy - 28 day. NCCP National SACT Regimen. HSE. The Republic of Ireland's Health Service Executive (HSE) has approved ribociclib in combination with an aromatase inhibitor or fulvestrant as an initial endocrine-based treatment option for the treatment of patients who are women with (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.