are involved in the growth and spread of cancer cells and in the blood vessels that supply the tumours, where they are involved in the development of new blood vessels. By blocking these enzymes, Sutent can reduce the growth and spread of the cancer and cut off the blood supply that keeps cancer cells growing.
How has it been studied?
Sutent was compared with placebo (a dummy treatment) in 312 patients with GIST whose previous treatment with imatinib had failed and in 171 patients with worsening pancreatic neuroendocrine tumours that could not be removed with surgery.. Sutent was also compared with another anticancer medicine, interferon alfa, in 750 patients with metastatic renal cell carcinoma whose cancer had not been treated before.
The main measure of effectiveness in all of the studies was how long the patients lived without their tumours getting worse.
What benefits has it shown during the studies?
Sutent was more effective than placebo in treating GIST and pancreatic neuroendocrine tumours. Patients with GIST taking Sutent lived for an average of 27.3 weeks without the disease getting worse, compared with 6.4 weeks in the patients taking placebo. For pancreatic neuroendocrine tumours the figures were 11.4 months in the Sutent group and 5.5 months in the placebo group.
In metastatic renal cell carcinoma, patients taking Sutent lived for an average of 47.3 weeks without their disease worsening, compared with 22.0 weeks in the patients receiving interferon alfa.
What is the risk associated?
The most common side effects with Sutent (seen in more than 20% of patients) include fatigue (tiredness), gastrointestinal disorders (such as diarrhoea, feeling sick, inflammation of the lining of the mouth, indigestion and vomiting), skin discoloration, dysgeusia (taste disturbances) and loss of appetite. For the full list of all side effects reported with Sutent, see the package leaflet.
Sutent should not be used in people who may be hypersensitive (allergic) to sunitinib or any of the other ingredients.
Why has it been approved?
The CHMP decided that Sutent’s benefits are greater than its risks and recommended that it be given marketing authorisation.
Sutent was originally given ‘conditional approval’. This means that there was more evidence to come about the medicine, in particular in the treatment of renal cell carcinoma. As the company has supplied the additional information necessary, the authorisation has been switched from conditional to full approval.
Further information
The European Commission granted a conditional marketing authorisation valid throughout the European Union for Sutent to Pfizer Ltd on 19 July 2006. This was switched to a full marketing authorisation on 11 January 2007. The marketing authorisation is valid for five years, after which it can be renewed. europa.eu/Find medicine/Human medicines/European Public Assessment Reports. For more information about treatment with Sutent, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
This summary was last updated in 11-2010.
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Name
SUTENT 25 mg hard capsules
Composition
Each capsule contains sunitinib malate, equivalent to 25.0 mg of sunitinib.
For a full list of excipients, see section 6.1.
Pharmaceutical Form
Hard capsule.
Gelatin capsules with caramel cap and orange body, printed with white ink &l
