Regulatory approval

Published by the European Medicines Agency. Approved

The European Medicines Agency (EMA) has authorized ribociclib in combination with an aromatase inhibitor or fulvestrant as an initial endocrine-based therapy for the treatment of patients who are women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer, or in women who have received prior endocrine therapy. In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist. This indication is based on three clinical trials: MONALEESA-2, MONALEESA-3, and MONALEESA-7, and MONALEESA-2 evaluated ribociclib in combination with letrozole, an aromatase inhibitor.

This is written in the approval document as:

Kisqali is indicated for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy, or in women who have received prior endocrine therapy.

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	Fulvestrant, Ribociclib
EMA (1)	HER2-negative, PR positive	Invasive Breast Carcinoma	Fulvestrant, Ribociclib
EMA (1)	ER positive, HER2-negative, PR positive	Invasive Breast Carcinoma	Fulvestrant, Ribociclib
EMA (1)	ER positive, HER2-negative	Invasive Breast Carcinoma	Letrozole, Ribociclib
EMA (1)	HER2-negative, PR positive	Invasive Breast Carcinoma	Letrozole, Ribociclib
EMA (1)	ER positive, HER2-negative, PR positive	Invasive Breast Carcinoma	Letrozole, Ribociclib

Contributions

Date	Contributor	Description
2024-10-20	Van Allen lab	Adding EMA approvals for use to database
2018-12-21	European Medicines Agency	Indication received approval from the European Commission.