Kisqali (ribociclib) [product monograph]. HC.

Regulatory approval published by the Health Canada.

Citation

Novartis Pharmaceuticals Canada Inc. Kisqali (ribociclib) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00075798.PDF. Revised May 2024. Accessed June 2025.

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Regulatory approvals

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

Indication Statements
KISQALI (ribociclib tablets) is indicated, in combination with an aromatase inhibitor for the treatment of pre/perimenopausal or postmenopausal women, or men ,with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, as initial endocrine-based therapy. 6
KISQALI (ribociclib tablets) is indicated, in combination with fulvestrant for the treatment of postmenopausal women, with HR-positive, HER2-negative advanced or metastatic breast cancer, 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.

Type Biomarker(s) Cancer type Therapy(ies)
Sensitivity (+) ER positive, HER2-negative Invasive Breast Carcinoma Anastrozole, Ribociclib
Sensitivity (+) HER2-negative, PR positive Invasive Breast Carcinoma Anastrozole, Ribociclib
Sensitivity (+) ER positive, HER2-negative, PR positive Invasive Breast Carcinoma Anastrozole, Ribociclib
Sensitivity (+) ER positive, HER2-negative Invasive Breast Carcinoma Letrozole, Ribociclib
Sensitivity (+) HER2-negative, PR positive Invasive Breast Carcinoma Letrozole, Ribociclib
Sensitivity (+) ER positive, HER2-negative, PR positive Invasive Breast Carcinoma Letrozole, Ribociclib
Sensitivity (+) ER positive, HER2-negative Invasive Breast Carcinoma Fulvestrant, Ribociclib
Sensitivity (+) HER2-negative, PR positive Invasive Breast Carcinoma Fulvestrant, Ribociclib
Sensitivity (+) ER positive, HER2-negative, PR positive Invasive Breast Carcinoma Fulvestrant, Ribociclib