Regulatory approval

Published by the Health Service Executive. Withdrawn

The Republic of Ireland's Health Service Executive (HSE) has approved palbociclib in combination with fulvestrant as a 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 who have received prior endocrine therapy.

This is written in the approval document as:

Treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in combination with fulvestrant in women who have received prior endocrine therapy

Reimbursement

N/A

Citation

Palbociclib Therapy - 28 day, 2025, version number 5, NCCP National SACT Regimen, NCCP, viewed 02/08/2026, https://healthservice.hse.ie/documents/6457/414_v5_Palbociclib_o9nHDn7.pdf

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies

Contributions

Date	Contributor	Description
2024-01-16	Van Allen lab	Adding HSE approvals for reimbursement to database
2018-06-01	Health Service Executive	Indication approved for reimbursement.