Regulatory approval
Published by the European Medicines Agency.
The European Medicines Agency (EMA) has authorized ribociclib in combination with an aromatase inhibitor or fulvestrant as an initial endocrine-based therapy for the treatment of patients who are women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer, 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. This indication is based on three clinical trials: MONALEESA-2, MONALEESA-3, and MONALEESA-7, and MONALEESA-2 evaluated ribociclib in combination with letrozole, an aromatase inhibitor.
This is written in the approval document as:
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.
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 October 2023. Accessed March 19, 2024.Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| 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 | Fulvestrant, Ribociclib | |
| Sensitivity (+) | HER2-negative, PR positive | Invasive Breast Carcinoma | Fulvestrant, Ribociclib | |
| Sensitivity (+) | ER positive, HER2-negative, PR positive | Invasive Breast Carcinoma | Fulvestrant, Ribociclib |