The U.S. Food and Drug Administration earlier today approved Sunitinib (Sutent?, Pfizer) for the treatment of advanced pancreatic neuroendocrine tumors located in the pancreas that cannot be removed by surgery.
Neuroendocrine tumors found in the pancreas are generally slower growing and less aggressive than the more common form of pancreatic cancer. It is estimated that there are fewer than 1,000 new cases in the United States each year, or lesss than 5% of all pancreatic cancer diagnoses and adenocarcinoma. Sunitinib is the second targeted drug to be approved this month for the treatment of pancreatic neuroendocrine tumors.
“FDA believes it is important to provide cancer patients with as many treatment options as possible,” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research. “The agency is committed to working with companies to bring innovative new therapies to the market and encourages companies to continue exploring additional uses for approved products.”
“The FDA approval today of sunitinib, and everolimus (Afinitor?, Novartis) just two weeks ago, is a significant step forward for patients with pancreatic neuroendocrine tumors. Treatment options for pancreatic neuroendocrine tumors have not been well-established, so the news of two new drugs approved by the FDA is exciting,” stated Julie Fleshman, President and CEO of the Pancreatic Cancer Action Network, a national (US) organization creating hope in a comprehensive way through research, patient support, community outreach and advocacy for a cure.
In order to gain approval, sunitinib 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.
Results from one study demonstrate that sunitinib provided benefit to patients by prolonging the median length of time they lived without the cancer spreading or worsening to 10.2 months compared to 5.4 months for patients who received placebo.
Sunitinib had previously been approved for the treatment of other cancer types, but needed to be tested specifically in patients with pancreatic neuroendocrine tumors. The Oncologic Drug Advisory Council recommended that both sunitinib and everolimus be approved for the treatment of pancreatic neuroendocrine tumors in mid-April, 2011. everolimus was approved by the FDA on May 5.
Sunitinib is also FDA-approved to treat patients with late-stage metastatic renal cell carcinoma) and to treat patients with GIST (gastrointestinal stromal tumor), a rare cancer of the stomach, bowel, or esophagus.