What is it?

Sutent is a medicine that contains the active substance sunitinib. It is available as capsules (orange: 12.5 mg; caramel and orange: 25 mg; yellow: 37.5 mg; caramel: 50 mg).

Table of Contents
What is it used for?
How is it used?
How does it work?
How has it been studied?
What benefits has it shown during the studies?
What is the risk associated?
Why has it been approved?

What is it used for?

Sutent is used to treat adults with the following types of cancer:

gastrointestinal stromal tumour GIST, a type of cancer of the stomach and bowel where there is uncontrolled growth of cells in the supporting tissues of these organs. Sutent is used in patients with GISTs that cannot be removed with surgery or have spread to other parts of the body. It is used after treatment with imatinib another anticancer medicine has failed

metastatic renal cell carcinoma, a type of kidney cancer, that has spread to other parts of the body

pancreatic neuroendocrine tumours tumours of the hormone-producing cells in the pancreas that have spread or cannot be removed with surgery. Sutent is used if the disease is getting worse and the tumour cells are well-differentiated similar to normal cells in the pancreas.

The medicine can only be obtained with a prescription.

How is it used?

Treatment with Sutent should be started by doctors who have experience in administering anticancer medicines.

For GIST and metastatic renal cell carcinoma, Sutent is given in six-week cycles, at a dose of 50 mg once a day for four weeks, followed by a two-week ?rest period?. The dose can be adjusted according to the patient?s response to the treatment, but should be kept within the range of 25 to 75 mg.

For pancreatic neuroendocrine tumours, Sutent is given at a dose of 37.5 mg once a day without a rest period. This dose may also be adjusted.

How does it work?

The active substance in Sutent, sunitinib, is a protein kinase inhibitor. This means that it blocks some specific enzymes known as protein kinases. These enzymes can be found in some receptors at the surface of cancer cells, where they 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.

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