Nivolumab Monotherapy. NCCP National SACT Regimen. HSE.

Regulatory approval published by the Health Service Executive.

Citation

Nivolumab Monotherapy, 2025, version number 11b, viewed 01/10/2025, https://www.hse.ie/eng/services/list/5/cancer/profinfo/chemoprotocols/genitourinary/483-nivolumab-240mg-monotherapy-14-day.pdf

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
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.	1

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	PD-L1 >= 1%	Bladder Urothelial Carcinoma	Nivolumab