Regulatory approval

Published by the Health Service Executive. Approved

As monotherapy for the adjuvant treatment of adults with muscle invasive urothelial carcinoma (MIUC) with tumour cell PD-L1 expression >= 1%, who are at high risk of recurrence after undergoing radical resection of MIUC, providing patients are unsuitable for adjuvant treatment with platinum based chemotherapy.

This is written in the approval document.

Reimbursement

ODMS

Citation

Nivolumab Monotherapy - 28 Day, 2026, version number 13a, NCCP National SACT Regimen, NCCP, viewed 02/08/2026, https://healthservice.hse.ie/documents/6499/484_Nivolumab_28-day_.pdf

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
HSE (1)	PD-L1 >= 1%	Bladder Urothelial Carcinoma	Nivolumab

Contributions

Date	Contributor	Description
2026-08-02	Van Allen lab	Initial curation of into moalmanac-db
2024-12-01	Health Service Executive	Indication approved for reimbursement.