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Home » Drug Information » FDA Approved Drugs » 2011
Medical Areas: Endocrinology | Gastroenterology | Oncology | Family Medicine

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Sutent (sunitinib malate)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Pfizer
Approval Status: Approved May 2011
Treatment Area: pancreatic neuroendocrine tumors

General Information

Sutent (sunitinib malate) an oral multi-kinase inhibitor and works by blocking multiple molecular targets implicated in the growth, proliferation and spread of cancer.

Sutent is specifically indicated for the treatment of progressive, well-differentiated pancreatic neuroendocrine tumors in patients with unresectable locally advanced or metastatic disease.

Sutent is supplied as a tablet for oral administration. The recommended dose for pancreatic meuroendocrine tumors is 37.5 mg taken orally once daily continuously without a scheduled off-treatment period.

Clinical Results

FDA Approval
The FDA approval of Sutent for pancreatic neuroendocrine tumors was based on a multi-center, international, randomized, double-blind placebo-controlled study in 171 subjects with unresectable pNET. The subjects were randomized to either 37.5 mg Sutent or placebo once daily without a scheduled off-treatment period. The primary endpoint was Progression-Free Survival (PFS). The median PFS in the Sutent arm was 10.2 months versus 5.4 months in the placebo arm. The Objective Response Rate was 9.3% versus 0%, respectively.

Side Effects

Adverse events associated with the use of Sutent for pNET may include, but are not limited to, the following:

  • fatigue
  • asthenia
  • diarrhea
  • nausea
  • stomatitis
  • vomiting
  • abdominal pain
  • hypertension
  • bleeding

Mechanism of Action

Sutent (sunitinib malate) an oral multi-kinase inhibitor and works by blocking multiple molecular targets implicated in the growth, proliferation and spread of cancer. Two Sutent targets, vascular endothelial growth factor receptor (VEGFR) and platelet-derived growth factor receptor (PDGFR), are expressed by many types of solid tumors and are thought to play a crucial role in angiogenesis, the process by which tumors acquire blood vessels, oxygen and nutrients needed for growth. Sutent also inhibits other targets important to tumor growth, including KIT, FLT3 and RET.

Literature References

Raymond E, Dahan L, Raoul JL, Bang YJ, Borbath I, Lombard-Bohas C, Valle J, Metrakos P, Smith D, Vinik A, Chen JS, Hörsch D, Hammel P, Wiedenmann B, Van Cutsem E, Patyna S, Lu DR, Blanckmeister C, Chao R, Ruszniewski P Sunitinib malate for the treatment of pancreatic neuroendocrine tumors. The New England Journal of Medicine 2011 Feb 10;364(6):501-13

O'Reilly EM, Niedzwiecki D, Hall M, Hollis D, Bekaii-Saab T, Pluard T, Douglas K, Abou-Alfa GK, Kindler HL, Schilsky RL, Goldberg RM; Cancer and Leukemia Group B A Cancer and Leukemia Group B phase II study of sunitinib malate in patients with previously treated metastatic pancreatic adenocarcinoma (CALGB 80603). The Oncologist 2010;15(12):1310-9. Epub 2010 Dec 10

Additional Information

For additional information regarding Sutent or pancreatic neuroendocrine tumors, please visit the Sutent web page.