# Renal cell carcinoma

The EU has approved 25 indications of 15 drugs in renal cell carcinoma. None of them needs a biomarker result. 6 tumour-agnostic approvals also apply when the tumour carries the alteration.

## Approved indications

### No biomarker required

| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| [Pembrolizumab](https://oncolabels.com/drugs/pembrolizumab) (Keytruda) | None | Monotherapy | Adjuvant | Following nephrectomy, or following nephrectomy and resection of metastatic lesions; Increased risk of recurrence |
| [Avelumab](https://oncolabels.com/drugs/avelumab) (Bavencio) | None | + axitinib | 1st line, advanced | - |
| [Bevacizumab](https://oncolabels.com/drugs/bevacizumab) (Avastin) | None | + interferon alfa-2a | 1st line, advanced | - |
| [Cabozantinib](https://oncolabels.com/drugs/cabozantinib) (Cabometyx) | None | + nivolumab | 1st line, advanced | - |
| [Cabozantinib](https://oncolabels.com/drugs/cabozantinib) (Cabometyx) | None | Monotherapy | 1st line, advanced | Intermediate or poor risk |
| [Ipilimumab](https://oncolabels.com/drugs/ipilimumab) (Yervoy) | None | + nivolumab | 1st line, advanced | Intermediate/poor-risk |
| [Lenvatinib](https://oncolabels.com/drugs/lenvatinib) (Kisplyx) | None | + pembrolizumab | 1st line, advanced | - |
| [Nivolumab](https://oncolabels.com/drugs/nivolumab) (Opdivo) | None | + cabozantinib | 1st line, advanced | - |
| [Nivolumab](https://oncolabels.com/drugs/nivolumab) (Opdivo) | None | + ipilimumab | 1st line, advanced | Intermediate/poor-risk |
| [Pazopanib](https://oncolabels.com/drugs/pazopanib) (Votrient) | None | Monotherapy | 1st line, advanced | - |
| [Pembrolizumab](https://oncolabels.com/drugs/pembrolizumab) (Keytruda) | None | + axitinib | 1st line, advanced | - |
| [Pembrolizumab](https://oncolabels.com/drugs/pembrolizumab) (Keytruda) | None | + lenvatinib | 1st line, advanced | - |
| [Temsirolimus](https://oncolabels.com/drugs/temsirolimus) (Torisel) | None | Monotherapy | 1st line, advanced | At least three of six prognostic risk factors |
| [Tivozanib](https://oncolabels.com/drugs/tivozanib) (Fotivda) | None | Monotherapy | 1st line, advanced | - |
| [Axitinib](https://oncolabels.com/drugs/axitinib) (Inlyta) | None | Monotherapy | 2nd line, advanced | Failure of prior treatment with sunitinib or a cytokine |
| [Cabozantinib](https://oncolabels.com/drugs/cabozantinib) (Cabometyx) | None | Monotherapy | 2nd line, advanced | After prior vascular endothelial growth factor (VEGF)-targeted therapy |
| [Everolimus](https://oncolabels.com/drugs/everolimus) (Afinitor) | None | Monotherapy | 2nd line, advanced | Progressed on or after treatment with VEGF-targeted therapy |
| [Lenvatinib](https://oncolabels.com/drugs/lenvatinib) (Kisplyx) | None | + everolimus | 2nd line, advanced | After one prior vascular endothelial growth factor (VEGF)-targeted therapy |
| [Nivolumab](https://oncolabels.com/drugs/nivolumab) (Opdivo) | None | Monotherapy | 2nd line, advanced | After prior therapy |
| [Pazopanib](https://oncolabels.com/drugs/pazopanib) (Votrient) | None | Monotherapy | 2nd line, advanced | After prior cytokine therapy for advanced disease |
| [Tivozanib](https://oncolabels.com/drugs/tivozanib) (Fotivda) | None | Monotherapy | 2nd line, advanced | After one prior treatment with cytokine therapy; VEGFR and mTOR pathway inhibitor-naïve |
| [Belzutifan](https://oncolabels.com/drugs/belzutifan) (Welireg) | None | Monotherapy | 3rd line+, advanced | Clear cell only; Progressed following two or more lines of therapy that included a PD-(L)1 inhibitor and at least two VEGF-targeted therapies |
| [Belzutifan](https://oncolabels.com/drugs/belzutifan) (Welireg) | None | Monotherapy | Early | Von Hippel-Lindau disease; localised procedures are unsuitable |
| [Sorafenib](https://oncolabels.com/drugs/sorafenib) (Nexavar) | None | Monotherapy | Advanced | Failed prior interferon-alpha or interleukin-2 based therapy, or considered unsuitable for such therapy |
| [Sunitinib](https://oncolabels.com/drugs/sunitinib) (Sutent) | None | Monotherapy | Advanced | - |

## 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), Renal cell carcinoma, 1st line, advanced: “KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of advanced renal cell carcinoma in adults (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Pembrolizumab** (Keytruda), Renal cell carcinoma, 1st line, advanced: “KEYTRUDA, in combination with lenvatinib, is indicated for the first-line treatment of advanced renal cell carcinoma in adults (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Pembrolizumab** (Keytruda), Renal cell carcinoma, adjuvant: “KEYTRUDA as monotherapy is indicated for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions (for selection criteria, see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/keytruda-epar-product-information_en.pdf)
- **Nivolumab** (Opdivo), Renal cell carcinoma, 1st line, advanced: “OPDIVO in combination with ipilimumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/opdivo-epar-product-information_en.pdf)
- **Nivolumab** (Opdivo), Renal cell carcinoma, 1st line, advanced: “OPDIVO in combination with cabozantinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/opdivo-epar-product-information_en.pdf)
- **Nivolumab** (Opdivo), Renal cell carcinoma, 2nd line, advanced: “OPDIVO as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/opdivo-epar-product-information_en.pdf)
- **Avelumab** (Bavencio), Renal cell carcinoma, 1st line, advanced: “Bavencio in combination with axitinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC) (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/bavencio-epar-product-information_en.pdf)
- **Everolimus** (Afinitor), Renal cell carcinoma, 2nd line, advanced: “Afinitor is indicated for the treatment of patients with advanced renal cell carcinoma, whose disease has progressed on or after treatment with VEGF-targeted therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/afinitor-epar-product-information_en.pdf)
- **Cabozantinib** (Cabometyx), Renal cell carcinoma, 1st line, advanced: “CABOMETYX is indicated as monotherapy for advanced renal cell carcinoma
- as first-line treatment of adult patients with intermediate or poor risk (see section 5.1),” [SmPC](https://www.ema.europa.eu/en/documents/product-information/cabometyx-epar-product-information_en.pdf)
- **Cabozantinib** (Cabometyx), Renal cell carcinoma, 2nd line, advanced: “CABOMETYX is indicated as monotherapy for advanced renal cell carcinoma
- in adults following prior vascular endothelial growth factor (VEGF)-targeted therapy (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/cabometyx-epar-product-information_en.pdf)
- **Cabozantinib** (Cabometyx), Renal cell carcinoma, 1st line, advanced: “CABOMETYX, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/cabometyx-epar-product-information_en.pdf)
- **Belzutifan** (Welireg), Renal cell carcinoma, 3rd line+, advanced: “WELIREG is indicated as monotherapy for the treatment of adult patients with advanced clear cell renal cell carcinoma that progressed following two or more lines of therapy that included a PD-(L)1 inhibitor and at least two VEGF-targeted therapies.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/welireg-epar-product-information_en.pdf)
- **Belzutifan** (Welireg), Renal cell carcinoma, early: “WELIREG is indicated as monotherapy for the treatment of adult patients with von Hippel-Lindau disease who require therapy for associated, localised renal cell carcinoma (RCC), central nervous system (CNS) haemangioblastomas, or pancreatic neuroendocrine tumours (pNET), and for whom localised procedures are unsuitable.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/welireg-epar-product-information_en.pdf)
- **Sunitinib** (Sutent), Renal cell carcinoma, advanced: “Sutent is indicated for the treatment of advanced/metastatic renal cell carcinoma (MRCC) in adults.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/sutent-epar-product-information_en.pdf)
- **Bevacizumab** (Avastin), Renal cell carcinoma, 1st line, advanced: “Bevacizumab in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/avastin-epar-product-information_en.pdf)
- **Ipilimumab** (Yervoy), Renal cell carcinoma, 1st line, advanced: “YERVOY in combination with nivolumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/yervoy-epar-product-information_en.pdf)
- **Sorafenib** (Nexavar), Renal cell carcinoma, advanced: “Nexavar is indicated for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon-alpha or interleukin-2 based therapy or are considered unsuitable for such therapy.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/nexavar-epar-product-information_en.pdf)
- **Lenvatinib** (Kisplyx), Renal cell carcinoma, 1st line, advanced: “Kisplyx is indicated for the treatment of adults with advanced renal cell carcinoma (RCC):
 in combination with pembrolizumab, as first-line treatment (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/kisplyx-epar-product-information_en.pdf)
- **Lenvatinib** (Kisplyx), Renal cell carcinoma, 2nd line, advanced: “in combination with everolimus, following one prior vascular endothelial growth factor (VEGF)-targeted therapy (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/kisplyx-epar-product-information_en.pdf)
- **Pazopanib** (Votrient), Renal cell carcinoma, 1st line, advanced: “Votrient is indicated in adults for the first-line treatment of advanced renal cell carcinoma (RCC) and for patients who have received prior cytokine therapy for advanced disease.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/votrient-epar-product-information_en.pdf)
- **Pazopanib** (Votrient), Renal cell carcinoma, 2nd line, advanced: “Votrient is indicated in adults for the first-line treatment of advanced renal cell carcinoma (RCC) and for patients who have received prior cytokine therapy for advanced disease.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/votrient-epar-product-information_en.pdf)
- **Axitinib** (Inlyta), Renal cell carcinoma, 2nd line, advanced: “Inlyta is indicated for the treatment of adult patients with advanced renal cell carcinoma (RCC) after failure of prior treatment with sunitinib or a cytokine.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/inlyta-epar-product-information_en.pdf)
- **Temsirolimus** (Torisel), Renal cell carcinoma, 1st line, advanced: “Torisel is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC) who have at least three of six prognostic risk factors (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/torisel-epar-product-information_en.pdf)
- **Tivozanib** (Fotivda), Renal cell carcinoma, 1st line, advanced: “Fotivda is indicated for the first line treatment of adult patients with advanced renal cell carcinoma (RCC) and for adult patients who are VEGFR and mTOR pathway inhibitor-naïve following disease progression after one prior treatment with cytokine therapy for advanced RCC.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/fotivda-epar-product-information_en.pdf)
- **Tivozanib** (Fotivda), Renal cell carcinoma, 2nd line, advanced: “Fotivda is indicated for the first line treatment of adult patients with advanced renal cell carcinoma (RCC) and for adult patients who are VEGFR and mTOR pathway inhibitor-naïve following disease progression after one prior treatment with cytokine therapy for advanced RCC.” [SmPC](https://www.ema.europa.eu/en/documents/product-information/fotivda-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/renal-cell-carcinoma