Regulatory approval
Published by the Health Service Executive.
The Republic of Ireland's Health Service Executive (HSE) has approved ribociclib in combination with an aromatase inhibitor or fulvestrant as an initial endocrine-based treatment option for the treatment of patients who are women with (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 is written in the approval document as:
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.
Citation
Ribociclib Therapy - 28 day, 2020, version number 4, NCCP National SACT Regimen, NCCP, viewed 03/04/2024, https://www.hse.ie/eng/services/list/5/cancer/profinfo/chemoprotocols/breast/525-ribociclib-therapy-28-day.pdfTherapeutic 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 |