Viewpoints / Position Papers
Sutent© gains FDA approval to treat advanced pancreatic neuroendocrine tumors
On Friday, May 20, 2011, the U.S. Food and Drug Administration (FDA) announced that the drug
Sutent© (sunitinib) has been approved for the treatment of advanced pancreatic neuroendocrine
tumors. Sutent© is manufactured by the pharmaceutical company Pfizer. Earlier this month, the FDA
also approved the Novartis drug Afinitor© to treat pancreatic neuroendocrine tumors. Pancreatic
neuroendocrine tumors make up less than five percent of all pancreatic cancer diagnoses, and are
typically a slower growing and less aggressive tumor than the more common type of pancreatic cancer,
pancreatic adenocarcinoma. To learn more about pancreatic neuroendocrine tumors, please click here.
In order to gain approval, Sutent© underwent clinical trials in the U.S. and several other countries
to show that the drug was effective and safe for patients with pancreatic neuroendocrine tumors.
Sutent© had previously been approved for the treatment of other cancer types, but needed to be tested
specifically in patients with pancreatic neuroendocrine tumors. The Phase 3 clinical trial included two
groups of patients randomly chosen to either receive Sutent© or best supportive care for pancreatic
neuroendocrine tumors. The trial ended up being discontinued early, due to a marked positive response
observed in patients receiving Sutent© compared to those getting best supportive care. The most
frequent side effects of Sutent© were diarrhea, nausea, vomiting, weakness and fatigue.
The Oncologic Drug Advisory Council recommended that Sutent© and Afinitor© be approved for the
treatment of pancreatic neuroendocrine tumors in mid-April, 2011. Unlike chemotherapy drugs that
kill any cell that is rapidly growing, both Sutent© and Afinitor© are considered targeted drugs. Targeted
drugs are designed to specifically attack cancer cells and spare normal cells.
Now that Sutent© and Afinitor© have been approved to treat pancreatic neuroendocrine tumors,
patients can be prescribed these drugs by their oncologists. However, the approval of these drugs
does not impact treatment for patients diagnosed with the more common form of pancreatic cancer,
The Pancreatic Cancer Action Network encourages all patients to consider clinical trials when exploring
treatment options. For more information about ongoing clinical trials or other questions about
pancreatic cancer diagnosis and treatment, please contact a Pancreatic Cancer Action Network Patient
and Liaison Services (PALS) Associate toll-free at 877-272-6226 or email firstname.lastname@example.org. PALS
Associates are available M-F 7am-5pm Pacific Time.