Regulatory approval

Published by the Food and Drug Administration. Approved

KISQALI is a kinase inhibitor indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy.

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.

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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 Fulvestrant, Ribociclib
FDA (1) HER2-negative, PR positive Invasive Breast Carcinoma Fulvestrant, Ribociclib
FDA (1) ER positive, HER2-negative, PR positive Invasive Breast Carcinoma Fulvestrant, Ribociclib