Sutent for Rare Type of Pancreatic Cancer Approved by FDA
Author: U.S. Food and Drug Administration
Synopsis and Key Points:
Sutent (sunitinib) approved for progressive neuroendocrine cancerous tumors located in the pancreas that cannot be removed by surgery or have spread to other parts of the body.
Main DigestThe U.S. Food and Drug Administration has approved Sutent (sunitinib) to treat patients with progressive neuroendocrine cancerous tumors located in the pancreas that cannot be removed by surgery or that have spread to other parts of the body (metastatic).
Neuroendocrine tumors found in the pancreas are slow-growing and rare. It is estimated that there are fewer than 1,000 new cases in the United States each year.
This is the second new approval by the FDA to treat patients with this disease; on May 5, the agency approved Afinitor (everolimus).
"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 safety and effectiveness of Sutent was established in a single study of 171 patients with metastatic (late-stage) or locally advanced (disease that could not be removed with surgery) disease who received Sutent or a placebo (sugar pill). The study was designed to measure the length of time a patient lived before their disease spread or worsened (progression-free survival).
Results from the study demonstrate that Sutent 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.
In patients treated with Sutent for neuroendocrine pancreatic tumors, the most commonly reported side effects included diarrhea, nausea, vomiting, fatigue, anorexia, high blood pressure, energy loss (asthenia), stomach (abdominal) pain, changes in hair color, inflammation of the mouth (stomatitis), and a decrease in infection-fighting white blood cells (neutropenia).
Sutent is also FDA-approved to treat patients with late-stage kidney cancer (metastatic renal cell carcinoma) and to treat patients with GIST (gastrointestinal stromal tumor), a rare cancer of the stomach, bowel, or esophagus.
Sutent is marketed by New York City-based Pfizer.
For more information:
FDA: Office of Oncology Drug Products
FDA: Approved Drugs: Questions and Answers
NCI: Pancreatic Cancer
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
- 1 - Safety and Effectiveness of Consumer Hand Sanitizers : U.S. Food and Drug Administration (2019/04/11)
- 2 - Scammers Target Consumers with Fake FDA Warning Letters : U.S. Food and Drug Administration (2018/07/13)
- 3 - Automated Insulin Delivery and Monitoring System for Younger Pediatric Patients Approved by FDA : U.S. Food and Drug Administration (FDA) (2018/06/21)
- 4 - FDA Approves Glucose Monitoring System with Sensor and App for Adults with Diabetes : U.S. Food and Drug Administration (FDA) (2018/06/21)
- 5 - Toxoplasmosis Parasite Infection Test : U.S. Food and Drug Administration (2011/05/24)
- 6 - Generic Version of EpiPen Approved by U.S. FDA : U.S. Food and Drug Administration (2018/08/19)
- 7 - US FDA Authorizes First Fully Interoperable Continuous Glucose Monitoring System : U.S. Food and Drug Administration (2018/03/29)
• Disabled World is strictly a news and information website provided for general informational purpose only and does not constitute medical advice. Materials presented are in no way meant to be a substitute for professional medical care by a qualified practitioner, nor should they be construed as such. Any 3rd party offering or advertising on disabled-world.com does not constitute endorsement by Disabled World.
• Please report outdated or inaccurate information to us.