Regulatory approval

Published by the Health Canada. Approved

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.

This is written in the approval document.

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.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
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

Contributions

Date	Contributor	Description
2024-10-30	Van Allen lab	Initial access of FDA approvals