Regulatory approval

Published by the European Medicines Agency. Approved

Kisqali in combination with an aromatase inhibitor for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer at high risk of recurrence. In pre- or perimenopausal women, or in men, the aromatase inhibitor should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.

This is written in the approval document.

Citation

Novartis Europharm Limited. Kisqali (ribociclib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/kisqali-epar-product-information_en.pdf. Revised April 2025. Accessed September 4, 2025.

Therapeutic response

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

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

Contributions

Date	Contributor	Description
2025-08-29	Van Allen lab	On 2024-12-16, the EMA published an EPAR - Assessment report - Variation for Kisqali (ribociclib) that added an extension indication to ribociclib in combination with an aromatase inhibitor for the treatment of the adjuvant treatment of patients with HR-positive, HER2-negative early breast cancer at high risk of recurrence.
2024-11-27	European Medicines Agency	Indication received approval from the European Commission.