Regulatory approval
Published by the Health Service Executive. Approved
The Republic of Ireland's Health Service Executive (HSE) has approved ribociclib in combination with an aromatase inhibitor as a treatment option for the adjuvant treatment of patients with hormone receptor positive (HR+), human epidermal growth factor 2 (HER2)-negative early breast cancer at high risk of recurrence. 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:
In combination with an aromatase inhibitor (AI) is indicated for the adjuvant treatment of patients with hormone receptor positive (HR+), human epidermal growth factor 2 (HER2)-negative early breast cancer at high risk of recurrence.
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 | Anastrozole, Goserelin, Ribociclib | |
| HSE (1) | HER2-negative, PR positive | Invasive Breast Carcinoma | Anastrozole, Goserelin, Ribociclib | |
| HSE (1) | ER positive, HER2-negative, PR positive | Invasive Breast Carcinoma | Anastrozole, Goserelin, Ribociclib | |
| HSE (1) | ER positive, HER2-negative | Invasive Breast Carcinoma | Goserelin, Letrozole, Ribociclib | |
| HSE (1) | HER2-negative, PR positive | Invasive Breast Carcinoma | Goserelin, Letrozole, Ribociclib | |
| HSE (1) | ER positive, HER2-negative, PR positive | Invasive Breast Carcinoma | Goserelin, Letrozole, Ribociclib |
Contributions
| Date | Contributor | Description |
|---|---|---|
| 2025-10-01 | Health Service Executive | Indication approved for reimbursement. |
| 2024-01-16 | Van Allen lab | Adding HSE approvals for reimbursement to database |