Regulatory approval

Published by the Health Service Executive. Approved

As monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin-containing chemotherapy whose tumours express PD-L1 with a combined positive score (CPS) >= 10.

This is written in the approval document.

Reimbursement

ODMS

Citation

Pembrolizumab 200mg Monotherapy, 2026, version number 16, NCCP National SACT Regimen, NCCP, viewed 02/08/2026, https://healthservice.hse.ie/documents/6903/455_V15b__Pembrolizumab_200mg_Monotherapy.pdf

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
HSE (1)	PD-L1 (CPS) >= 10	Bladder Urothelial Carcinoma	Pembrolizumab