Regulatory approval
Published by the European Medicines Agency.
The European Medicines Agency (EMA) has authorized ribociclib in combination with an aromatase inhibitor 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. In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist. This indication is based on NATALEE (NCT03701334) was a randomized (1:1), open-label, multicenter study, where participants received goserelin and either letrozole or anastrozole, in addition to ribociclib.
This is written in the approval document as:
Kisqali in combination with an aromatase inhibitor 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. In pre- or perimenopausal women, or in men, the aromatase inhibitor should be combined with a luteinising hormone-releasing hormone (LHRH) agonist.
Citation
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 | Anastrozole, Goserelin, Ribociclib | |
| Sensitivity (+) | HER2-negative, PR positive | Invasive Breast Carcinoma | Anastrozole, Goserelin, Ribociclib | |
| Sensitivity (+) | ER positive, HER2-negative, PR positive | Invasive Breast Carcinoma | Anastrozole, Goserelin, Ribociclib | |
| Sensitivity (+) | ER positive, HER2-negative | Invasive Breast Carcinoma | Goserelin, Letrozole, Ribociclib | |
| Sensitivity (+) | HER2-negative, PR positive | Invasive Breast Carcinoma | Goserelin, Letrozole, Ribociclib | |
| Sensitivity (+) | ER positive, HER2-negative, PR positive | Invasive Breast Carcinoma | Goserelin, Letrozole, Ribociclib |