What is Sutent?
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).
What is Sutent used for?
Sutent is indicated for the treatment of adults suffering from the following forms of tumors:
- Stromal tumor of the gastrointestinal tract (GIST), a form of cancer that affects the stomach and intestines characterized by an uncontrolled growth of cells in the tissues that support these organs. Sutent is indicated in patients with tumors that cannot be surgically removed or that are "metastatic" (ie that have spread to other organs), when therapy with imatinib (another anticancer medicine) has given no results or is not tolerated by the patient;
- metastatic renal cell carcinoma (RCC), a form of kidney cancer that has spread to other organs.
The medicine can only be obtained with a prescription.
How is Sutent used?
Sutent therapy should be initiated by a physician experienced in the treatment of GIST or metastatic RCC.
Sutent is given in six-week cycles, at a dose of 50 mg taken daily for four weeks, followed by two weeks without treatment. The recommended dose of Sutent is 50 mg, but may be adequate (increased or decreased) depending on the patient's response, provided it is not less than 25 mg or greater than 87.5 mg.
How does Sutent work?
The active substance in Sutent, sunitinib, is a protein kinase inhibitor. That is, it blocks some specific enzymes known as protein kinases. These enzymes are found in some receptors located on the surface of tumor cells, such as the "KIT" receptors on the surface of GIST cells and analogous receptors on the surface of RCC cells, where they are involved in the growth and spread of cancer cells. By blocking these enzymes, Sutent can reduce the growth and spread of the tumor.
How has Sutent been studied?
The effects of Sutent were first tested in experimental models before being studied in humans.
Sutent in GIST was studied in 312 patients whose previous imatinib therapy had failed or was not tolerated. Sutent was compared with placebo (a dummy treatment). In metastatic RCC, Sutent was examined in 750 patients whose cancer had not been treated before. The study compared the effects of Sutent and interferon-alpha (the standard first-line treatment for this type of tumor). The main measure of effectiveness was the period of survival of patients without worsening the tumor.
What benefit has Sutent shown during the studies?
Sutent was more effective than placebo in GIST. Patients treated with Sutent lived on average 27.3 weeks without the disease getting worse compared to 6.4 weeks for placebo-treated patients. Intermediate results (calculated before the end of the study) were good enough to interrupt the study in advance and so that patients treated with placebo would switch to Sutent treatment.
In RCC, patients treated with Sutent lived an average of 47.3 weeks without the disease getting worse compared to 22.0 weeks for patients treated with interferon alfa.
What is the risk associated with Sutent?
The most common side effects of Sutent (seen in over 20% of patients) are fatigue, gastrointestinal disorders (such as diarrhea, nausea, inflammation of the epithelial lining of the mouth, indigestion and vomiting), skin discoloration, dysgeusia (alteration of the faculty of taste) and lack 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 are hypersensitive (allergic) to sunitinib or any of the other substances.
Why was Sutent approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Sutent's benefits are greater than its risks for the treatment of inoperable and / or metastatic malignant GIST after failure of imatinib mesylate therapy due to resistance or intolerance and for metastatic RCC treatment. The Committee recommended that Sutent be given marketing authorization.
Sutent first obtained a "conditional approval". This means that other evidence should have been provided on the medicine, in particular regarding the treatment of renal cell carcinoma. Since the pharmaceutical company provided the necessary complementary information, on 11 January 2007 the authorization was changed from "conditioned" to "normal" .
More information on Sutent:
On 19 July 2006, the European Commission granted a marketing authorization valid for Sutent, which is valid throughout the European Union, to Pfizer Ltd.
For the full EPENT of Sutent, click here.
Last update of this summary: 04-2009.
