# Urothelial carcinoma

The EU has approved 20 indications of 9 drugs in urothelial carcinoma. 4 of them need a biomarker result: PD-L1 (3) and FGFR (1). 6 tumour-agnostic approvals also apply when the tumour carries the alteration.

## Approved indications

### FGFR3 alteration

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Erdafitinib](https://oncolabels.com/drugs/erdafitinib) (Balversa) | Susceptible FGFR3 genetic alterations | Monotherapy | 2nd line, advanced | After at least one line of therapy containing a PD-1 or PD-L1 inhibitor in the unresectable or metastatic treatment setting |

### 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 |

### No biomarker required

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Durvalumab](https://oncolabels.com/drugs/durvalumab) (Imfinzi) | None | + gemcitabine and cisplatin | Neoadjuvant, early | Muscle-invasive only; Then adjuvant monotherapy after surgery |
| [Enfortumab vedotin](https://oncolabels.com/drugs/enfortumab-vedotin) (Padcev) | None | + pembrolizumab | Neoadjuvant, early | Muscle-invasive only; Then adjuvant enfortumab vedotin + pembrolizumab after surgery |
| [Pembrolizumab](https://oncolabels.com/drugs/pembrolizumab) (Keytruda) | None | + enfortumab vedotin | Neoadjuvant, early | Muscle-invasive only; Then adjuvant pembrolizumab + enfortumab vedotin after surgery |
| [Durvalumab](https://oncolabels.com/drugs/durvalumab) (Imfinzi) | None | Monotherapy | Adjuvant, early | Muscle-invasive only; After neoadjuvant durvalumab + gemcitabine and cisplatin and radical cystectomy |
| [Enfortumab vedotin](https://oncolabels.com/drugs/enfortumab-vedotin) (Padcev) | None | + pembrolizumab | Adjuvant, early | Muscle-invasive only; After neoadjuvant enfortumab vedotin + pembrolizumab and radical cystectomy |
| [Pembrolizumab](https://oncolabels.com/drugs/pembrolizumab) (Keytruda) | None | + enfortumab vedotin | Adjuvant, early | Muscle-invasive only; After neoadjuvant pembrolizumab + enfortumab vedotin and radical cystectomy |
| [Enfortumab vedotin](https://oncolabels.com/drugs/enfortumab-vedotin) (Padcev) | None | + pembrolizumab | 1st line, advanced | Eligible for platinum-containing chemotherapy |
| [Nivolumab](https://oncolabels.com/drugs/nivolumab) (Opdivo) | None | + cisplatin and gemcitabine | 1st line, advanced | - |
| [Pembrolizumab](https://oncolabels.com/drugs/pembrolizumab) (Keytruda) | None | + enfortumab vedotin | 1st line, advanced | - |
| [Avelumab](https://oncolabels.com/drugs/avelumab) (Bavencio) | None | Monotherapy | Maintenance, advanced | Progression-free following platinum-based chemotherapy |
| [Atezolizumab](https://oncolabels.com/drugs/atezolizumab) (Tecentriq) | None | Monotherapy | 2nd line, advanced | After prior platinum-containing chemotherapy |
| [Enfortumab vedotin](https://oncolabels.com/drugs/enfortumab-vedotin) (Padcev) | None | Monotherapy | 2nd line, advanced | Previously received a platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor |
| [Nivolumab](https://oncolabels.com/drugs/nivolumab) (Opdivo) | None | Monotherapy | 2nd line, advanced | After failure of prior platinum-containing therapy |
| [Pembrolizumab](https://oncolabels.com/drugs/pembrolizumab) (Keytruda) | None | Monotherapy | 2nd line, advanced | After prior platinum-containing chemotherapy |
| [Nadofaragene firadenovec](https://oncolabels.com/drugs/nadofaragene-firadenovec) (Adstiladrin) | None | Monotherapy | Early | Non-muscle-invasive only; BCG-unresponsive; carcinoma in situ (CIS) with or without papillary tumours |
| [Nogapendekin alfa inbakicept](https://oncolabels.com/drugs/nogapendekin-alfa-inbakicept) (Anktiva) | None | + Bacillus Calmette-Guérin (BCG) | Early | Non-muscle-invasive with carcinoma in situ only; BCG-unresponsive; with or without papillary tumours Ambiguous in the label (stage): check the SmPC. |

## Tumour-agnostic approvals

Approved for any solid tumour that carries the alteration, wherever the tumour started.

### EpCAM

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Catumaxomab](https://oncolabels.com/drugs/catumaxomab) (Korjuny) | EpCAM-positive | Monotherapy | 2nd line | Malignant ascites; not eligible for further systemic anticancer therapy Ambiguous in the label (tumour site, line of therapy): check the SmPC. |

### HER2

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Trastuzumab deruxtecan](https://oncolabels.com/drugs/trastuzumab-deruxtecan) (Enhertu) | HER2-positive (IHC 3+) | Monotherapy | 2nd line, advanced | After prior treatment; No satisfactory treatment options |

### NTRK fusion

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Entrectinib](https://oncolabels.com/drugs/entrectinib) (Rozlytrek) | NTRK fusion | Monotherapy | Any line | No prior NTRK inhibitor; Older than 1 month; disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity; no satisfactory treatment options |
| [Larotrectinib](https://oncolabels.com/drugs/larotrectinib) (Vitrakvi) | NTRK fusion | Monotherapy | Any line | Locally advanced, metastatic or where surgical resection is likely to result in severe morbidity; no satisfactory treatment options |
| [Repotrectinib](https://oncolabels.com/drugs/repotrectinib) (Augtyro) | NTRK fusion | Monotherapy | Advanced | Prior NTRK inhibitor, or no prior NTRK inhibitor and treatment options not targeting NTRK provide limited clinical benefit or have been exhausted; Aged 12 years and older |

### RET fusion

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Selpercatinib](https://oncolabels.com/drugs/selpercatinib) (Retsevmo) | RET fusion | Monotherapy | Advanced | Treatment options not targeting RET provide limited clinical benefit, or have been exhausted; Aged 2 years and older |

## Label wording

- **Pembrolizumab** (Keytruda), Urothelial carcinoma, neoadjuvant, early: “KEYTRUDA, in combination with enfortumab vedotin, as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment, is indicated for the treatment of adults with resectable muscle invasive bladder cancer (MIBC).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Pembrolizumab** (Keytruda), Urothelial carcinoma, adjuvant, early: “KEYTRUDA, in combination with enfortumab vedotin, as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment, is indicated for the treatment of adults with resectable muscle invasive bladder cancer (MIBC).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Pembrolizumab** (Keytruda), Urothelial carcinoma, 1st line, advanced: “KEYTRUDA, in combination with enfortumab vedotin, is indicated for the first-line treatment of unresectable or metastatic urothelial carcinoma in adults.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Pembrolizumab** (Keytruda), Urothelial carcinoma, 2nd line, advanced: “KEYTRUDA as monotherapy is indicated for the treatment of locally advanced or metastatic urothelial carcinoma in adults who have received prior platinum-containing chemotherapy (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **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)
- **Nivolumab** (Opdivo), Urothelial carcinoma, 1st line, advanced: “OPDIVO in combination with cisplatin and gemcitabine is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/opdivo-epar-product-information_en.pdf)
- **Nivolumab** (Opdivo), Urothelial carcinoma, 2nd line, advanced: “OPDIVO as monotherapy is indicated for the treatment of locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum-containing therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/opdivo-epar-product-information_en.pdf)
- **Avelumab** (Bavencio), Urothelial carcinoma, maintenance, advanced: “Bavencio is indicated as monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic urothelial carcinoma (UC) who are progression-free following platinum-based chemotherapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/bavencio-epar-product-information_en.pdf)
- **Enfortumab vedotin** (Padcev), Urothelial carcinoma, neoadjuvant, early: “Padcev, in combination with pembrolizumab, as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment, is indicated for the treatment of adult patients with resectable muscle invasive bladder cancer (MIBC).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/padcev-epar-product-information_en.pdf)
- **Enfortumab vedotin** (Padcev), Urothelial carcinoma, adjuvant, early: “Padcev, in combination with pembrolizumab, as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment, is indicated for the treatment of adult patients with resectable muscle invasive bladder cancer (MIBC).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/padcev-epar-product-information_en.pdf)
- **Enfortumab vedotin** (Padcev), Urothelial carcinoma, 1st line, advanced: “Padcev, in combination with pembrolizumab, is indicated for the first-line treatment of adult patients with unresectable or metastatic urothelial cancer who are eligible for platinum-containing chemotherapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/padcev-epar-product-information_en.pdf)
- **Enfortumab vedotin** (Padcev), Urothelial carcinoma, 2nd line, advanced: “Padcev as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a programmed death receptor-1 or programmed death-ligand 1 inhibitor (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/padcev-epar-product-information_en.pdf)
- **Durvalumab** (Imfinzi), Urothelial carcinoma, neoadjuvant, early: “IMFINZI in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by IMFINZI as monotherapy adjuvant treatment after radical cystectomy, is indicated for the treatment of adults with resectable muscle invasive bladder cancer (MIBC).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/imfinzi-epar-product-information_en.pdf)
- **Durvalumab** (Imfinzi), Urothelial carcinoma, adjuvant, early: “IMFINZI in combination with gemcitabine and cisplatin as neoadjuvant treatment, followed by IMFINZI as monotherapy adjuvant treatment after radical cystectomy, is indicated for the treatment of adults with resectable muscle invasive bladder cancer (MIBC).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/imfinzi-epar-product-information_en.pdf)
- **Atezolizumab** (Tecentriq), Urothelial carcinoma, 2nd line, advanced: “Tecentriq as monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic UC:
 after prior platinum-containing chemotherapy, or” [SmPC](https://www.ema.europa.eu/en/documents/product-information/tecentriq-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)
- **Erdafitinib** (Balversa), Urothelial carcinoma, 2nd line, advanced: “Balversa as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC), harbouring susceptible FGFR3 genetic alterations who have previously received at least one line of therapy containing a PD-1 or PD-L1 inhibitor in the unresectable or metastatic treatment setting (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/balversa-epar-product-information_en.pdf)
- **Nadofaragene firadenovec** (Adstiladrin), Urothelial carcinoma, early: “ADSTILADRIN is indicated as monotherapy for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/adstiladrin-epar-product-information_en.pdf)
- **Nogapendekin alfa inbakicept** (Anktiva), Urothelial carcinoma, early: “ANKTIVA in combination with Bacillus Calmette-Guérin (BCG) is indicated for the treatment of adult patients with BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumours.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/anktiva-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