Sutent (sunitinib)
- Region
- 🇪🇺 EU
- Active substance
- sunitinib
- Company
- Pfizer Limited
- Status
- Authorised
- Therapeutic area
- Gastrointestinal Stromal Tumors; Carcinoma, Renal Cell; Neuroendocrine Tumors
- EU approval
- Wed 19 Jul 2006
- Application
- EMEA/H/C/000687
- ATC
- L01EX01
- Official record
- www.ema.europa.eu
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).
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Sunitinib Accord Authorised · Accord Healthcare S.L.U.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.