This is a summary of the European public assessment report (EPAR) for Sutent. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Sutent.
Therapeutic Indication
### Therapeutic indication **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 mesilate 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 with disease progression in adults. Experience with Sutent as first-line treatment is limited (see section 5.1).
Therapeutic Area (MeSH)
N/AATC Code
L01EX01
ATC Item
sunitinib
Pharmacotherapeutic Group
Antineoplastic agents
Active Substance (Summary)
INN / Common Names
N/A| Substance | CAS | Monograph |
|---|---|---|
| sunitinib | N/A | 舒尼替尼 |
EMA Name
Sutent
Medicine Name
Sutent
Aliases
N/ANo risk management plan link.
