Regulatory approval
Published by the Health Service Executive. Approved
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.
This is written in the approval document.
Reimbursement
CDS
Citation
Therapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.
| Organizations | Biomarkers | Cancer types | Therapies | |
|---|---|---|---|---|
| HSE (1) | ER positive, HER2-negative | Invasive Breast Carcinoma | Fulvestrant, Ribociclib | |
| HSE (1) | HER2-negative, PR positive | Invasive Breast Carcinoma | Fulvestrant, Ribociclib | |
| HSE (1) | ER positive, HER2-negative, PR positive | Invasive Breast Carcinoma | Fulvestrant, Ribociclib | |
| HSE (1) | ER positive, HER2-negative | Invasive Breast Carcinoma | Letrozole, Ribociclib | |
| HSE (1) | HER2-negative, PR positive | Invasive Breast Carcinoma | Letrozole, Ribociclib | |
| HSE (1) | ER positive, HER2-negative, PR positive | Invasive Breast Carcinoma | Letrozole, Ribociclib |