Sunitinib
Sunitinib (Sutent, Pfizer Limited) has 3 EU-approved indications in 3 tumour types.
| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Gastrointestinal stromal tumour1 | |||
None | Monotherapy | 2L advanced | After imatinib treatment (failure due to resistance or intolerance) |
| Neuroendocrine tumours1 | |||
None | Monotherapy | Any line advanced | Well-differentiated pancreatic NET only; Disease progression |
| Renal cell carcinoma1 | |||
None | Monotherapy | Any line advanced | None |
Full text of section 4.1 (therapeutic indications)
Gastrointestinal stromal tumour (GIST) Sutent is indicated for the treatment of unresectable and/or metastatic malignant gastrointestinal stromal tumour (GIST) in adults after failure of imatinib treatment due to resistance or intolerance. Metastatic renal cell carcinoma (MRCC) Sutent is indicated for the treatment of advanced/metastatic renal cell carcinoma (MRCC) in adults. Pancreatic neuroendocrine tumours (pNET) Sutent is indicated for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumours (pNET) with disease progression in adults.
Label history
1 change to the Sutent label since 2025, none of them to the indications. Newest first, in the words of EMA's record of each procedure.
Changes