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.
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. |
|
| 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. |
|
| 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. |
|
Therapeutic response
Precision oncology relationships for therapeutic response derived from this document.
| Organizations |
Biomarkers |
Cancer types |
Therapies |
|