National Cancer Institute NCI Cancer Bulletin: A Trusted Source for Cancer Research News
May 31, 2011 • Volume 8 / Number 11

FDA Update

Sunitinib Approved to Treat Pancreatic Neuroendocrine Tumors

The Food and Drug Administration (FDA) has approved sunitinib (Sutent) to treat patients with pancreatic neuroendocrine tumors (PNET) that cannot be removed by surgery or that have metastasized. This is the second new drug approval for this disease in a month; the FDA approved everolimus (Afinitor) to treat PNET in early May.

The FDA based its approval on the results of a study that showed that patients who received sunitinib lived longer without their disease spreading or worsening than those who received a placebo—a median of 10.2 months compared with 5.4 months.

Sunitinib is a small-molecule tyrosine kinase inhibitor that blocks cell proliferation and tumor blood vessel formation. Commonly reported side effects included diarrhea, vomiting, fatigue, high blood pressure, abdominal pain, stomatitis, and neutropenia. The FDA has also approved sunitinib to treat late-stage kidney cancer and gastrointestinal stromal tumors.