Ribociclib
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| 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