FDA approves SUTENT for treatment of pancreatic NET

May 21 2011

Pfizer Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved SUTENT® (sunitinib malate) as the first anti-VEGF therapy to treat progressive, well-differentiated pancreatic neuroendocrine tumors (NET) in patients with unresectable locally advanced or metastatic disease. Pancreatic NET is a rare cancer reported in two to four people per million annually worldwide.

“Pancreatic NET is a highly vascular tumor, and as the first anti-VEGF therapy approved for this disease, SUTENT represents a treatment that attacks a key component of tumor growth.”

"We are delighted that SUTENT has been granted approval by the FDA as an effective treatment option for individuals with pancreatic NET. This approval represents the third disease indication for SUTENT, which was approved by the FDA in 2006 for treatment of patients with advanced kidney cancer and imatinib-resistant or intolerant gastrointestinal stromal tumor (GIST)," said Dr. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs, Pfizer Oncology Business Unit. "Pfizer is committed to improving the lives of those with cancer. This approval is good news for the physicians, patients and caregivers who have had limited treatment options for this rare and difficult-to-treat tumor."

The FDA approval is based on data from the SUN 1111 pivotal Phase 3 trial that demonstrated SUTENT provided a clinically significant improvement in progression-free survival (PFS) compared to placebo (10.2 versus 5.4 months). Treatment with SUTENT also yielded a statistically significant improvement in tumor response, with an objective response rate (ORR) of 9.3 percent (95% CI: 3.2, 15.4) .

"This approval is welcome news for physicians who have struggled to find a treatment option that shows a substantial clinical benefit in treating advanced pancreatic NET," said Dr. Eric Raymond, professor of medical oncology and head of University Department of Medical Oncology (Service Inter Hospitalier de Cancerologie) Bichat-Beaujon, Clichy, France and principal investigator of the SUN 1111 Phase 3 trial. "Pancreatic NET is a highly vascular tumor, and as the first anti-VEGF therapy approved for this disease, SUTENT represents a treatment that attacks a key component of tumor growth."