Kisqali is a cancer medicine used to treat breast cancer that is locally advanced (has spread nearby) or metastatic (has spread to other parts of the body). It can only be used when the cancer cells have receptors (targets) for certain sex hormones on their surface (HR-positive) and do not have large quantities of another receptor called HER2 (HER2-negative).
Kisqali should always be used in combination with hormonal treatment that reduces the effect of oestrogen: either fulvestrant (which blocks oestrogen receptors) or an aromatase inhibitor (which reduces oestrogen levels).
If Kisqali is used in women before the menopause or around the time of menopause (pre-menopausal or peri-menopausal), it should also be given in combination with an LHRH inhibitor (a medicine that blocks the effects of luteinising hormone-releasing hormone).
Kisqali contains the active substance ribociclib.
Kisqali : EPAR - Medicine overview (PDF/134.79 KB)
First published: 31/08/2017
Last updated: 21/07/2020
Kisqali : EPAR - Risk-management-plan summary (PDF/68.4 KB)
First published: 30/01/2019
Last updated: 26/07/2022
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Novartis Europharm Limited
|Date of issue of marketing authorisation valid throughout the European Union||
26/07/2022 Kisqali - EMEA/H/C/004213 - II/0035
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.
In pre‑ or perimenopausal women, the endocrine therapy should be combined with a luteinising hormone‑releasing hormone (LHRH) agonist.