Regulatory approval

Published by the Health Service Executive.

The Republic of Ireland's Health Service Executive (HSE) has approved pembrolizumab 200mg in combination with carboplatin (AUC 5) and weekly paclitaxel 80mg/m^2 followed by doxorubicin and cyclophosphamide (AC 60/600) for reimbursement as a treatment option for the neoadjuvant treatment, and then pembrolizumab as a monotherapy treatment as an adjuvant treatment after surgery, of locally advanced or early stage triple negative breast cancer at high risk of recurrence in adult patients.

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.

Citation

Pembrolizumab 200mg, CARBOplatin AUC 5 and weekly PACLitaxel 80mg/m 2 followed by DOXOrubicin and cycloPHOSphamide (AC 60/600) Therapy, 2024, version number 1, NCCP National SACT Regimen, NCCP, viewed 21/07/2024, https://www.hse.ie/eng/services/list/5/cancer/profinfo/chemoprotocols/breast/857-pembrolizumab-200mg-carboplatin-auc-5-and-weekly-paclitaxel-80mg-m2-followed-by-doxorubicin-and-cyclophosphamide.pdf

Therapeutic response

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

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	ER negative, HER2-negative, PR negative	Invasive Breast Carcinoma	Carboplatin, Cyclophosphamide, Doxorubicin, Paclitaxel, Pembrolizumab