Kisqali (ribociclib) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration. Deprecated

Citation

Novartis Pharmaceuticals Corporation. Kisqali (ribociclib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209092s008lbl.pdf. Revised December 2021. Accessed October 6, 2026.

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Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication Statements
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 an aromatase inhibitor as initial endocrine-based therapy. 6
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. 3

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

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