Regulatory approval

Published by the Health Service Executive. Approved

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.

This is written in the approval document.

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