Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that ER positive, HER2-negative status confers therapeutic sensitivity to Goserelin, Letrozole, Ribociclib in patients with Invasive Breast Carcinoma.
The European Medicines Agency (EMA) has authorized ribociclib in combination with an aromatase inhibitor for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer at high risk of recurrence. In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist. This indication is based on NATALEE (NCT03701334) was a randomized (1:1), open-label, multicenter study, where participants received goserelin and either letrozole or anastrozole, in addition to ribociclib.
This statement is based on a regulatory approval from the European Medicines Agency:
Kisqali in combination with an aromatase inhibitor for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer at high risk of recurrence. In pre- or perimenopausal women, or in men, the aromatase inhibitor should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.