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/00083872.PDF. Revised March 2026. Accessed April 2026.

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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
KISQALI (ribociclib tablets) is indicated, 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-III early breast cancer at high risk of recurrence. 6

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organization(s) Biomarker(s) Cancer type Therapy(ies)
HC (1) ER positive, HER2-negative Invasive Breast Carcinoma Fulvestrant, Ribociclib
HC (1) HER2-negative, PR positive Invasive Breast Carcinoma Fulvestrant, Ribociclib
HC (1) ER positive, HER2-negative, PR positive Invasive Breast Carcinoma Fulvestrant, Ribociclib
HC (1) ER positive, HER2-negative Invasive Breast Carcinoma Anastrozole, Ribociclib
HC (1) HER2-negative, PR positive Invasive Breast Carcinoma Anastrozole, Ribociclib
HC (1) ER positive, HER2-negative, PR positive Invasive Breast Carcinoma Anastrozole, Ribociclib
HC (1) ER positive, HER2-negative Invasive Breast Carcinoma Letrozole, Ribociclib
HC (1) HER2-negative, PR positive Invasive Breast Carcinoma Letrozole, Ribociclib
HC (1) ER positive, HER2-negative, PR positive Invasive Breast Carcinoma Letrozole, Ribociclib
HC (1) ER positive, HER2-negative Invasive Breast Carcinoma Anastrozole, Goserelin, Ribociclib
HC (1) HER2-negative, PR positive Invasive Breast Carcinoma Anastrozole, Goserelin, Ribociclib
HC (1) ER positive, HER2-negative, PR positive Invasive Breast Carcinoma Anastrozole, Goserelin, Ribociclib
HC (1) ER positive, HER2-negative Invasive Breast Carcinoma Goserelin, Letrozole, Ribociclib
HC (1) HER2-negative, PR positive Invasive Breast Carcinoma Goserelin, Letrozole, Ribociclib
HC (1) ER positive, HER2-negative, PR positive Invasive Breast Carcinoma Goserelin, Letrozole, Ribociclib