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 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 indication is based on three clinical trials: MONALEESA-2, MONALEESA-3, and MONALEESA-7, and MONALEESA-2 evaluated ribociclib in combination with letrozole, an aromatase inhibitor.

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.

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

Contributions

Date	Contributor	Description
2024-01-16	Van Allen lab	Adding HSE approvals for reimbursement to database
2019-02-01	Health Service Executive	Indication approved for reimbursement.