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.
Histology
Disease setting
| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| No biomarker required25 | ||||
Keytruda | None | Monotherapy | Adj. | Following nephrectomy, or following nephrectomy and resection of metastatic lesions; Increased risk of recurrence |
Bavencio | None | + axitinib | 1L advanced | None |
Avastin | None | + interferon alfa-2a | 1L advanced | None |
Cabometyx | None | + nivolumab | 1L advanced | None |
Cabometyx | None | Monotherapy | 1L advanced | Intermediate or poor risk |
Yervoy | None | + nivolumab | 1L advanced | Intermediate/poor-risk |
Kisplyx | None | + pembrolizumab | 1L advanced | None |
Opdivo | None | + cabozantinib | 1L advanced | None |
Opdivo | None | + ipilimumab | 1L advanced | Intermediate/poor-risk |
Votrient | None | Monotherapy | 1L advanced | None |
Keytruda | None | + axitinib | 1L advanced | None |
Keytruda | None | + lenvatinib | 1L advanced | None |
Torisel | None | Monotherapy | 1L advanced | At least three of six prognostic risk factors |
Fotivda | None | Monotherapy | 1L advanced | None |
Inlyta | None | Monotherapy | 2L advanced | Failure of prior treatment with sunitinib or a cytokine |
Cabometyx | None | Monotherapy | 2L advanced | After prior vascular endothelial growth factor (VEGF)-targeted therapy |
Afinitor | None | Monotherapy | 2L advanced | Progressed on or after treatment with VEGF-targeted therapy |
Kisplyx | None | + everolimus | 2L advanced | After one prior vascular endothelial growth factor (VEGF)-targeted therapy |
Opdivo | None | Monotherapy | 2L advanced | After prior therapy |
Votrient | None | Monotherapy | 2L advanced | After prior cytokine therapy for advanced disease |
Fotivda | None | Monotherapy | 2L advanced | After one prior treatment with cytokine therapy; VEGFR and mTOR pathway inhibitor-naïve |
Weliregconditional | None | Monotherapy | 3L+ 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 |
Weliregconditional | None | Monotherapy | Any line early | Von Hippel-Lindau disease; localised procedures are unsuitable |
Nexavar | None | Monotherapy | Any line advanced | Failed prior interferon-alpha or interleukin-2 based therapy, or considered unsuitable for such therapy |
Sutent | None | Monotherapy | Any line advanced | None |
Tumour-agnostic approvals6
Approved for any solid tumour that carries the alteration, wherever the tumour started.
| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| EpCAM1 | ||||
Korjuny | Monotherapy | 2L | Malignant ascites; not eligible for further systemic anticancer therapy | |
| HER21 | ||||
Enhertuconditional | HER2-positive (IHC 3+) | Monotherapy | 2L advanced | After prior treatment; No satisfactory treatment options |
| NTRK fusion3 | ||||
Rozlytrekconditional | 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 | |
Vitrakviconditional | Monotherapy | Any line | Locally advanced, metastatic or where surgical resection is likely to result in severe morbidity; no satisfactory treatment options | |
Augtyroconditional | Monotherapy | Any line 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 fusion1 | ||||
Retsevmo | Monotherapy | Any line advanced | Treatment options not targeting RET provide limited clinical benefit, or have been exhausted; Aged 2 years and older | |
Label wording25
The sentence from section 4.1 of the SmPC that each indication above comes from.
- Pembrolizumab (Keytruda)
KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of advanced renal cell carcinoma in adults (see section 5.1).
- Pembrolizumab (Keytruda)
KEYTRUDA, in combination with lenvatinib, is indicated for the first-line treatment of advanced renal cell carcinoma in adults (see section 5.1).
- Pembrolizumab (Keytruda)
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).
- Nivolumab (Opdivo)
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).
- Nivolumab (Opdivo)
OPDIVO in combination with cabozantinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (see section 5.1).
- Nivolumab (Opdivo)
OPDIVO as monotherapy is indicated for the treatment of advanced renal cell carcinoma after prior therapy in adults.
- Avelumab (Bavencio)
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).
- Everolimus (Afinitor)
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.
- Cabozantinib (Cabometyx)
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),
- Cabozantinib (Cabometyx)
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).
- Cabozantinib (Cabometyx)
CABOMETYX, in combination with nivolumab, is indicated for the first-line treatment of advanced renal cell carcinoma in adults (see section 5.1).
- Belzutifan (Welireg)
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.
- Belzutifan (Welireg)
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.
- Sunitinib (Sutent)
Sutent is indicated for the treatment of advanced/metastatic renal cell carcinoma (MRCC) in adults.
- Bevacizumab (Avastin)
Bevacizumab in combination with interferon alfa-2a is indicated for first line treatment of adult patients with advanced and/or metastatic renal cell cancer.
- Ipilimumab (Yervoy)
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).
- Sorafenib (Nexavar)
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.
- Lenvatinib (Kisplyx)
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).
- Lenvatinib (Kisplyx)
in combination with everolimus, following one prior vascular endothelial growth factor (VEGF)-targeted therapy (see section 5.1).
- Pazopanib (Votrient)
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.
- Pazopanib (Votrient)
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.
- Axitinib (Inlyta)
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.
- Temsirolimus (Torisel)
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).
- Tivozanib (Fotivda)
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.
- Tivozanib (Fotivda)
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.