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SUTENT Granted Approval for Treatment of Patients with Pancreatic Neuroendocrine Tumors
Monday, May 23, 2011 - 15:02
The US Food and Drug Administration (FDA) has granted approval to Pfizer, Inc. for SUTENT ® (sunitinib malate) to treat patients with pancreatic neuroendocrine tumors.
The FDA approved SUTENT for patients with progressive, well-differentiated pancreatic neuroendocrine tumors that are unresectable locally advanced, or metastatic. The approval was based on a double-blind, randomized, placebo-controlled, phase III trial with progression free survival as the primary endpoint. This phase III trial was conducted at institutions worldwide and the results were published in the New England Journal of Medicine.
SUTENT is the first anti-VEGF FDA-approved therapy for patients with pancreatic neuroendocrine tumors and only the second therapy approved by the FDA to treat pancreatic neuroendocrine tumor patients since 1982.
“Pancreatic neuroendocrine tumor 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,” said Dr. Eric Raymond, professor of medical oncology and head of the University Department of Medical Oncology Bichat-Beaujon, Clichy, France.
SUTENT’s approval represents an important advance in treating pancreatic neuroendocrine tumors. Any patients considering this, or any other, treatment should always consult with a physician well-versed in treating neuroendocrine cancers. Please consult CFCF’s Doctor Database or call 617-948-2514 for more information on finding an experienced clinician.
All cells require an adequate blood supply to survive. Cancer cells, since they replicate faster than normal cells, require an even greater blood supply. As a result, many tumors, including pancreatic neuroendocrine tumors, undergo angiogenesis, the development of new blood vessels. Vascular endothelial growth factor (VEGF) is a highly specialized chemical signal that cells produce in order to stimulate new blood vessel growth.
SUTENT is an oral multi-kinase inhibitor that works by blocking multiple molecular targets (including VEGF) implicated in the growth and proliferation of cancer. SUTENT is also FDA-approved to treat gastrointestinal stromal tumors and advanced renal cell carcinoma. To date, more than 100,000 patients have been treated with SUTENT worldwide (Pfizer, 2011).
Important Safety Information about SUTENT (sunitinib malate)
Hepatotoxicity has been observed in clinical trials and post-marketing experience. This hepatotoxicity may be severe, and deaths have been reported. It is recommended to monitor liver function tests before initiation of treatment, during each cycle of treatment, and as clinically indicated. SUTENT should be interrupted for Grade 3 or 4 drug-related hepatic adverse events and discontinued if there is no resolution. SUTENT should not be restarted if patients subsequently experience severe changes in liver function tests or have other signs and symptoms of liver failure.
Women of child bearing age who are (or become) pregnant during therapy should be informed of the potential for fetal harm while on SUTENT.
Decreases in left ventricular ejection fraction (LVEF) to below the lower limit of normal (LLN) and cardiac failure, including death, have been observed. Patients with concomitant cardiac conditions should be carefully monitored for clinical signs and symptoms of congestive heart failure. Patients should be monitored for hypertension and treated as needed with standard antihypertensive therapy. Complete blood counts (CBCs) with platelet count and serum chemistries should be performed at the beginning of each treatment cycle for patients receiving treatment with SUTENT.
The most common adverse reactions in gastrointestinal stromal tumor, renal cell carcinoma and pancreatic neuroendocrine tumor clinical trials were diarrhea, fatigue, asthenia, nausea, mucositis/stomatitis, anorexia, vomiting, neutropenia, hypertension, dyspepsia, abdominal pain, constipation, rash, hand-foot syndrome, skin discoloration, hair color changes, altered taste and bleeding (Pfizer, 2011).
For complete prescribing information please click here.
About Pancreatic Neuroendocrine Cancer
Neuroendocrine tumors are a type of cancer that can originate almost anywhere in the body. The most common sites from which neuroendocrine tumors arise are the lungs, appendix, small intestine, rectum, and pancreas. Neuroendocrine tumors that arise in the pancreas are called “pancreatic neuroendocrine tumors,” “islet cell tumors,” or “pancreatic endocrine tumors.” When neuroendocrine tumors originate in other areas, they are most commonly classified as “carcinoid cancer.” Currently, between 11,000 and 12,000 new cases of carcinoid cancer are diagnosed each year in the United States, but the number has been increasing by six percent annually.
About the Caring for Carcinoid Foundation
The Caring for Carcinoid Foundation (CFCF) is dedicated to discovering cures for carcinoid cancer, pancreatic neuroendocrine cancer, and related neuroendocrine cancers. Along with its focus on research, CFCF is committed to supporting patients, families, friends, and caregivers by providing them with complete and up-to-date information. CFCF directs 100 percent of all individual donations to breakthrough scientific research. This is made possible by the generous support of CFCF’s board of directors, corporate sponsors and pro bono legal counsel, Proskauer Rose LLP. Since its inception, CFCF has awarded more than 6 million dollars in research grants to leading scientists at renowned institutions worldwide. For more information about CFCF, please visit http://www.caringforcarcinoid.org/ or call 617 948 2514 and ask to speak with Executive Director, Lauren Erb.
Pfizer media release 2011. SUTENT® Receives U.S. FDA Approval for Advanced Pancreatic Neuroendocrine Tumors. Retrieved from: http://www.pfizer.com/news/press_releases/pfizer_press_releases.jsp - guid=20110520006117en&source=RSS_2011&page=1