Regulatory approval

Published by the Health Service Executive. Approved

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.

This is written in the approval document.

Reimbursement

CDS

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.

Organizations	Biomarkers	Cancer types	Therapies
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