Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that HER2-negative, PR positive status confers therapeutic sensitivity to Anastrozole, Goserelin, Ribociclib in patients with Invasive Breast Carcinoma.
Health Canada approved ribociclib in combination with an aromatase inhibitor for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II-III early breast cancer at high risk of recurrence. This indication is based on NATALEE (LEE011 O12301C) 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 Health Canada:
KISQALI (ribociclib tablets) is indicated, in combination with an aromatase inhibitor for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II-III early breast cancer at high risk of recurrence.