# Ribociclib

Ribociclib (Kisqali, Novartis Europharm Limited) has 3 EU-approved indications in 1 tumour type. Each needs a biomarker result: Hormone receptor (3).

## Approved indications

### Breast cancer

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Hormone receptor-positive, HER2-negative | + an aromatase inhibitor | Adjuvant, early | 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 |
| Hormone receptor-positive, HER2-negative | + an aromatase inhibitor or fulvestrant | 1st line, advanced | Women; initial endocrine-based therapy; in pre- or perimenopausal women, the endocrine therapy should be combined with a LHRH agonist |
| Hormone receptor-positive, HER2-negative | + an aromatase inhibitor or fulvestrant | 2nd line, advanced | After prior endocrine therapy; Women; in pre- or perimenopausal women, the endocrine therapy should be combined with a LHRH agonist |

## Products

### Kisqali

- Company: Novartis Europharm Limited
- Target: CDK4/6 inhibitor
- Class: Cyclin-dependent kinase (CDK) inhibitors
- ATC: L01EF02
- EU approval: 22 Aug 2017
- Label revised: 19 Aug 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/kisqali-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/kisqali-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/kisqali

Mechanism (SmPC section 5.1): Ribociclib selectively inhibits CDK4 and CDK6, decreasing retinoblastoma protein phosphorylation and causing G1 cell cycle arrest and reduced proliferation.

## Label wording

- **Ribociclib** (Kisqali), Breast cancer, adjuvant, early: “Kisqali in combination with an aromatase inhibitor is indicated 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 (see section 5.1 for selection criteria).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/kisqali-epar-product-information_en.pdf)
- **Ribociclib** (Kisqali), Breast cancer, 1st line, advanced: “Kisqali is indicated for the treatment of women with HR-positive, 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.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/kisqali-epar-product-information_en.pdf)
- **Ribociclib** (Kisqali), Breast cancer, 2nd line, advanced: “Kisqali is indicated for the treatment of women with HR-positive, 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.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/kisqali-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/drugs/ribociclib