Regulatory approval
Published by the Health Service Executive.
The Republic of Ireland's Health Service Executive (HSE) has approved pembrolizumab (200mg) in combination with platinum and flouropyrimidine-based chemotherapy for reimbursement as a treatment option for the first-line treatment of adult patients with locally advanced unresectable or metastatic carcinoma of the oesophagus or HER-2 negative gastro-oesophageal junction adenocarcinoma whose tumors express PD-L1 with CPS >= 10.
This is written in the approval document as:
Pembrolizumab in combination with platinum and fluoropyrimidine-based chemotherapy, for the first line treatment of patients with locally advanced unresectable or metastatic carcinoma of the oesophagus or HER-2 negative gastro-oesophageal junction adenocarcinoma in adults whose tumours express PD-L1 with CPS >= 10.
Citation
Pembrolizumab 200mg, CISplatin 80mg/m2 and 5-Fluorouracil Infusional Therapy, 2024, version number 1c, NCCP National SACT Regimen, NCCP, viewed 04/04/2024, https://www.hse.ie/eng/services/list/5/cancer/profinfo/chemoprotocols/gastrointestinal/739-pembrolizumab-200mg-cisplatin-80mg-m2-and-5-fluorouracil-infusional-therapy.pdfTherapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | PD-L1 (CPS) >= 10 | Esophageal Adenocarcinoma | Cisplatin, Fluorouracil, Pembrolizumab | |
| Sensitivity (+) | HER2-negative, PD-L1 (CPS) >= 10 | Adenocarcinoma of the Gastroesophageal Junction | Cisplatin, Fluorouracil, Pembrolizumab |