SUTENT Receives European Approval for a New Indication in Progressive Pancreatic Neuroendocrine Tumors (NET)

First Targeted Therapy Approved for the Treatment of Pancreatic NET in Europe

06-Dec-2010 - USA

Pfizer Inc. announced that the European Commission has approved SUTENT® (sunitinib malate) for the treatment of unresectable or metastatic, well-differentiated pancreatic neuroendocrine tumors (NET) with disease progression in adults. Experience with SUTENT as initial treatment is limited in this disease. Pancreatic NET is a rare cancer reported in two to four people per million annually worldwide. Sutent is the first treatment to be approved for patients with pancreatic NET in twenty-five years.

The approval is based on results from a randomized, Phase 3 trial that demonstrated SUTENT more than doubled the time period that patients were free from disease progression or death. The progression-free survival (PFS) for SUTENT was 11.4 months vs. 5.5 months for placebo (p=0.0001) in 171 patients. Additionally, while the overall survival data were not mature at the time of analysis, the overall survival favored the SUTENT arm compared with placebo (9 vs. 21 deaths) (HR 0.409, p=0.0204).

"This approval represents a significant milestone in the management of pancreatic NET," said Dr. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs, Pfizer Oncology Business Unit. "SUTENT has been a standard of care for patients with advanced/metastatic renal cell carcinoma (RCC) and imatinib-refractory gastrointestinal stromal tumor (GIST) for several years, and we are proud that it is now a treatment option for patients in Europe with progressive pancreatic NET."

Although rare, the reported incidence of pancreatic NET appears to be rising, accounting for approximately nine percent of neuroendocrine tumors. Current treatment options have limited therapeutic benefit and the prognosis is poor for patients with advanced pancreatic NET.

"As the first anti-VEGF therapy to show a substantial clinical benefit in treating progressive pancreatic NET, SUTENT represents a novel therapeutic approach for this difficult-to–treat disease." said Dr. Eric Raymond, principal investigator of the pivotal Phase 3 study that led to the approval of Sutent for pancreatic NET in Europe. "Physicians in Europe will now be able to use a therapy with proven efficacy to treat this disease." Dr. Raymond is professor of medical oncology and head of University Department of Medical Oncology (Service Inter Hospitalier de Cancerologie) Bichat-Beaujon, Clichy, France.

SUTENT is also approved for the treatment of unresectable well-differentiated advanced and/or metastatic pancreatic neuroendocrine carcinoma in the Philippines, Switzerland, Colombia and Korea. In addition, it is under regulatory review for this indication in several other countries.

https://www.bionity.com/en/news/126931/sutent-receives-european-approval-for-a-new-indication-in-progressive-pancreatic-neuroendocrine-tumors-net.html