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 as an initial endocrine-based treatment option for the treatment of patients who are postmenopausal women with (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer.

This is written in the approval document as:

Treatment of postmenopausal women with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer as initial endocrine-based therapy in combination with an aromatase inhibitor.

Citation

Ribociclib Therapy - 28 day, 2024, version number 5, NCCP National SACT Regimen, NCCP, viewed 26/03/2026, https://healthservice.hse.ie/documents/6629/525_v6_Ribociclib_Metastatic_hghzyyD.pdf

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organization(s) Biomarker(s) Cancer type Therapy(ies)
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