# PD-L1 in urothelial carcinoma

3 EU-approved indications in urothelial carcinoma need a PD-L1 result: pembrolizumab (advanced), nivolumab (adjuvant) and atezolizumab (advanced).

## Approved indications

### PD-L1

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Nivolumab](https://oncolabels.com/drugs/nivolumab) (Opdivo) | Tumour cell PD-L1 expression ≥ 1% | Monotherapy | Adjuvant | Muscle-invasive only; After radical resection of MIUC; High risk of recurrence |
| [Atezolizumab](https://oncolabels.com/drugs/atezolizumab) (Tecentriq) | PD-L1 IC ≥ 5% | Monotherapy | Advanced | Cisplatin-ineligible |
| [Pembrolizumab](https://oncolabels.com/drugs/pembrolizumab) (Keytruda) | PD-L1 CPS ≥ 10 | Monotherapy | Advanced | Cisplatin-ineligible |

## Label wording

- **Pembrolizumab** (Keytruda), Urothelial carcinoma, advanced: “KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin-containing chemotherapy and whose tumours express PD-L1 with a combined positive score (CPS) ≥ 10 (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Nivolumab** (Opdivo), Urothelial carcinoma, adjuvant: “OPDIVO as monotherapy is indicated 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 (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/opdivo-epar-product-information_en.pdf)
- **Atezolizumab** (Tecentriq), Urothelial carcinoma, advanced: “who are considered cisplatin ineligible, and whose tumours have a PD-L1 expression ≥ 5% (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tecentriq-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/tumours/urothelial-carcinoma/pd-l1