Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that ER positive, HER2-negative, PR positive status confers therapeutic sensitivity to Anastrozole, Goserelin, Ribociclib in patients with Invasive Breast Carcinoma.
The U.S. Food and Drug Administration granted approval to 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 and III early breast cancer at high risk of recurrence. 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 Food and Drug Administration:
KISQALI is a kinase inhibitor indicated in combination with an aromatase inhibitor for the adjuvant treatment of adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III early breast cancer at high risk of recurrence.