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

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.

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	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

Contributions

Date	Contributor	Description
2024-01-16	Van Allen lab	Adding HSE approvals for reimbursement to database
2020-09-01	Health Service Executive	Indication approved for reimbursement.