Regulatory approval
Published by the Health Service Executive.
The Republic of Ireland's Health Service Executive (HSE) has approved pembrolizumab in combination with weekly carboplatin and paclitaxel followed by doxorubicin and cyclophosphamide for the neoadjuvant treatment, and then continued 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 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, weekly CARBOplatin AUC 1.5 and PACLitaxel 80mg/m 2 followed by DOXOrubicin and cycloPHOSphamide (AC 60/600) Therapy, 2024, version number 1, NCCP National SACT Regimen, NCCP, viewed 19/06/2024, https://www.hse.ie/eng/services/list/5/cancer/profinfo/chemoprotocols/breast/858-pembrolizumab-200mg-weekly-carboplatin-auc-1-5-and-paclitaxel-80mg-m2-followed-by-doxorubicin-and-cyclophosphamide.pdfTherapeutic 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 |