Regulatory approval

Published by the Health Service Executive. Approved

The Republic of Ireland's Health Service Executive (HSE) has approved pembrolizumab in combination with chemotherapy for reimbursement as a treatment option for the neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, of adult patients with locally advanced or early stage triple negative breast cancer at high risk of recurrence. This cited regimen is specifically for pembrolizumab 400mg, carboplatin AUC 5, and weekly paclitaxel 80mg/m^2 followed by dose dense doxorubicin and cyclophosphamide (AC 60/600) therapy.

This is written in the approval document as:

Pembrolizumab in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment after surgery, is indicated for the treatment of adults with locally advanced, or early stage triple negative breast cancer at high risk of recurrence.

Reimbursement

ODMS

Citation

Pembrolizumab 400mg, CARBOplatin AUC 5 and weekly PACLitaxel 80mg/m2 followed by Dose Dense DOXOrubicin and cycloPHOSphamide (AC 60/600) Therapy, 2025, version number 2, NCCP National SACT Regimen, NCCP, viewed 26/03/2026, https://healthservice.hse.ie/documents/6452/860_v2_Pembro_Carbo_AUC_5_Pacli_80_DDAC.pdf

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
HSE (1)	ER negative, HER2-negative, PR negative	Invasive Breast Carcinoma	Carboplatin, Cyclophosphamide, Doxorubicin, Paclitaxel, Pembrolizumab

Contributions

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