Navigation Links
FDA Approves Sutent for Rare Type of Pancreatic Cancer
Date:5/20/2011

SILVER SPRING, Md., May 20, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today 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).

(Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO)

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

http://www.fda.gov/AboutFDA/CentersOffices/CDER/ucm091745.htm

FDA: Approved Drugs: Questions and Answers

http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm054420.htm

NCI: Pancreatic Cancer

http://www.cancer.gov/cancertopics/types/pancreatic

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.

Media Inquiries: Erica Jefferson, 301-796-4988, erica.jefferson@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Approves Lillys Osteoporosis Drug EVISTA(R) (raloxifene HCl) to Reduce The Risk of Invasive Breast Cancer in Two Populations of Postmenopausal Women
2. Health Canada Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for HIV
3. FDA Approves Cymbalta(R) for Maintenance Treatment of Major Depressive Disorder
4. European Commission Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for Virologically Suppressed Adults With HIV-1 Infection
5. FDA Approves MiddleBrooks Amoxicillin PULSYS for Pharyngitis/Tonsillitis in Adolescents and Adults
6. FDA Approves XYZAL(R) (levocetirizine dihydrochloride) Oral Solution for the Relief of Seasonal and Year Round Allergies and Chronic Idiopathic Urticaria
7. UM Maryland Industrial Partnerships Program Approves 18 Collaborative Research Projects, Worth $4.4 Million, Between University Faculty, State Technology Companies
8. U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)
9. U.S. Food and Drug Administration Approves ORENCIA(R) (abatacept) for the Treatment of Moderate-to-Severe Polyarticular Juvenile Idiopathic Arthritis (JIA) in Patients Six Years and Older
10. FDA Approves HIFU Clinical Trial for Recurrent Prostate Cancer
11. EPA Approves XDS-CALUX(R) as Alternate Dioxin Test Method 4435
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/27/2016)... 27, 2016 Amarantus BioScience Holdings, Inc. ... products for Regenerative Medicine, Neurology and Orphan Diseases, today announced that ... at two upcoming investor conferences: SeeThru Equity MicroCap ... New York City , NY When: ... Marcum MicroCap Conference   Where: Grand Hyatt Hotel, 109 ...
(Date:5/26/2016)... May 26, 2016   Change Healthcare ... analytics, network solutions and technology-enabled services designed ... entered into a strategic channel partnership with ... software solutions and revenue cycle management services ... and rehabilitation clinics to optimize revenue, operational ...
(Date:5/25/2016)... and GERMANTOWN, Maryland , May 25, 2016 ... ; Frankfurt Prime Standard: QIA) today announced that the company ... Diagnostics GmbH to develop and commercialize predictive assays in oncology. ... as a marker to predict effectiveness of anthracycline treatment in ... "We are pleased to partner with Therawis, which developed the ...
Breaking Medicine Technology:
(Date:5/27/2016)... ... May 27, 2016 , ... With over 60 percent of acute stroke ... a sustainable product to aid in the rehabilitation process has steadily increased. Ekso Bionics ... individuals with hemiplegia due to stroke. , Ekso Bionics has now received clearance from ...
(Date:5/27/2016)... , ... May 27, 2016 , ... Beleza Medspa ... body fat composition regulations. This is the first time that Coolsculpting is being ... at least every six months to ensure they meet the prescribed body-fat standard, measured ...
(Date:5/27/2016)... ... May 27, 2016 , ... With a team ... and food industries. Aside from its GMP accreditation, Validation Center is also a ... certified products, services and staff. , Validation Center is ISO17025 accredited and only ...
(Date:5/26/2016)... ... May 26, 2016 , ... ... of thousands of defective respirators, according to court documents and SEC filings. ... William and Becky Tyler v. American Optical Corporation, Case No. BC588866, Los Angeles ...
(Date:5/26/2016)... Washington, D.C. (PRWEB) , ... May 26, 2016 , ... ... the men and women who lost their lives in military battle for the country. ... discount cards in 2015 to provide more programs that empower independence for disabled military ...
Breaking Medicine News(10 mins):