Regulatory approval

Published by the Food and Drug Administration. Approved

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.

This is written in the approval document.

Citation

Novartis Pharmaceuticals Corporation. Kisqali (ribociclib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209092Orig1s018lbl.pdf. Revised September 2024. Accessed October 30, 2024.

View API

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations Biomarkers Cancer types Therapies
FDA (1) ER positive, HER2-negative Invasive Breast Carcinoma Anastrozole, Goserelin, Ribociclib
FDA (1) HER2-negative, PR positive Invasive Breast Carcinoma Anastrozole, Goserelin, Ribociclib
FDA (1) ER positive, HER2-negative, PR positive Invasive Breast Carcinoma Anastrozole, Goserelin, Ribociclib
FDA (1) ER positive, HER2-negative Invasive Breast Carcinoma Goserelin, Letrozole, Ribociclib
FDA (1) HER2-negative, PR positive Invasive Breast Carcinoma Goserelin, Letrozole, Ribociclib
FDA (1) ER positive, HER2-negative, PR positive Invasive Breast Carcinoma Goserelin, Letrozole, Ribociclib