Kisqali (ribociclib) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

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.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
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.	6
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.	6

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	ER positive, HER2-negative	Invasive Breast Carcinoma	Fulvestrant, Ribociclib
Sensitivity (+)	HER2-negative, PR positive	Invasive Breast Carcinoma	Fulvestrant, Ribociclib
Sensitivity (+)	ER positive, HER2-negative, PR positive	Invasive Breast Carcinoma	Fulvestrant, Ribociclib
Sensitivity (+)	ER positive, HER2-negative	Invasive Breast Carcinoma	Letrozole, Ribociclib
Sensitivity (+)	HER2-negative, PR positive	Invasive Breast Carcinoma	Letrozole, Ribociclib
Sensitivity (+)	ER positive, HER2-negative, PR positive	Invasive Breast Carcinoma	Letrozole, Ribociclib
Sensitivity (+)	ER positive, HER2-negative	Invasive Breast Carcinoma	Anastrozole, Goserelin, Ribociclib
Sensitivity (+)	HER2-negative, PR positive	Invasive Breast Carcinoma	Anastrozole, Goserelin, Ribociclib
Sensitivity (+)	ER positive, HER2-negative, PR positive	Invasive Breast Carcinoma	Anastrozole, Goserelin, Ribociclib
Sensitivity (+)	ER positive, HER2-negative	Invasive Breast Carcinoma	Goserelin, Letrozole, Ribociclib
Sensitivity (+)	HER2-negative, PR positive	Invasive Breast Carcinoma	Goserelin, Letrozole, Ribociclib
Sensitivity (+)	ER positive, HER2-negative, PR positive	Invasive Breast Carcinoma	Goserelin, Letrozole, Ribociclib