Sunitinib malate


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Company: Pfizer
Approval Status: FDA Approved May 2011
Specific Treatments: pancreatic neuroendocrine tumors
Drug: Sunitinib malate



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.



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.



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



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.



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

Source: centerwatch