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 of Ribociclib
Biomarker requirementRegimenSettingConditions
Breast cancer3
Hormone receptor-positive, HER2-negative
+ an aromatase inhibitor
Adj.
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
1L
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
2L
advanced
After prior endocrine therapy; Women; in pre- or perimenopausal women, the endocrine therapy should be combined with a LHRH agonist
Full text of section 4.1 (therapeutic indications)

Early breast cancer 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). In pre- or perimenopausal women, or in men, the aromatase inhibitor should be combined with a luteinising hormone-releasing hormone (LHRH) agonist. Advanced or metastatic breast cancer 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. In pre- or perimenopausal women, the endocrine therapy should be combined with a LHRH agonist.

Label history

9 changes to the Kisqali label since 2025, none of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes