Navigation Links
FDA Approves New Treatment for Advanced Form of Kidney Cancer
Date:10/19/2009

SILVER SPRING, Md., Oct. 19 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Votrient (pazopanib), the sixth drug to be approved for kidney cancer since 2005.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO)

Votrient is an oral medication that interferes with angiogenesis, the growth of new blood vessels needed for solid tumors to grow and survive.

Votrient is intended for people with advanced renal cell carcinoma, a type of kidney cancer in which the cancerous cells are found in the lining of very small tubes (tubules) in the kidney. In 2009, approximately 49,000 people were diagnosed with renal cell carcinoma and 11,000 people died from the disease.

"The last five years have seen dramatic improvements in treatment options for patients with kidney cancer. Before 2005, the options available offered only limited effectiveness," said Richard Pazdur, M.D., director, Office of Oncology Drug Products in the FDA's Center for Drug Evaluation and Research.

The five other drugs approved for kidney cancer and their approval dates are: Sorafenib (December 2005), Sunitinib (January 2006), Temsirolimus (May 2007), Everolimus (March 2009), and Bevacizumab (July 2009).

The safety and effectiveness of Votrient was evaluated in a 435-patient study that examined a patient's progression-free survival - the length of time, following enrollment in the study, before the tumor began growing again or before the patient died. Progression-free survival averaged 9.2 months for patients receiving Votrient compared to 4.2 months for patients who did not receive the drug.

Adverse reactions included diarrhea, high blood pressure, hair color changes, nausea, loss of appetite, vomiting, fatigue, weakness, abdominal pain and headache. Votrient can also cause severe and fatal liver toxicity. Health care professionals should order blood tests to monitor liver function before and during treatment with the drug. Since Votrient can harm a fetus, it should not be used during pregnancy.

The drug has also been associated with heart rhythm irregularities. Patients receiving Votrient should be monitored with periodic electrocardiograms, which measure heart rhythm, and blood tests to monitor electrolytes since an electrolyte imbalance can lead to an irregular heart rhythm.

Votrient is manufactured by London-based GlaxoSmithKline.

Media Inquiries: Karen Riley, 301-796-4674, karen.riley@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Approves Elitek(R) (rasburicase) for Management of Plasma Uric Acid Levels in Adults with Leukemia, Lymphoma, and Solid Tumors Receiving Anti-Cancer Therapy
2. FDA Approves Cervarix, GlaxoSmithKlines Cervical Cancer Vaccine
3. U.S. Food and Drug Administration Approves CRESTOR(R) for Use in Pediatric Patients With Heterozygous Familial Hypercholesterolemia
4. Chinese Food and Drug Administration Approves Gabexate Mesylate as Pharmaceutical Raw Material
5. FDA Approves New Indication For Mirena(R) to Treat Heavy Menstrual Bleeding in IUD Users
6. US FDA Approves Extavia(R) - the First in a New Portfolio of Planned MS Therapies from Novartis to Help Patients with this Devastating Disease
7. Video: FDA Approves INVEGA(R) SUSTENNA(TM) for the Acute and Maintenance Treatment of Schizophrenia
8. FDA Approves Tekturna HCT(R) as Initial Treatment in Patients Unlikely to Achieve Their Blood Pressure Goals With a Single Agent
9. FDA Approves ADCIRCA(TM) (Tadalafil) Tablets for the Treatment of Pulmonary Arterial Hypertension
10. FDA Approves Vanda Pharmaceuticals Fanapt(TM) for the Treatment of Schizophrenia
11. FDA Approves an Expanded Indication for Peginterferon-Based Combination Therapy for Patients With Chronic Hepatitis C
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... 2016  In a startling report released today, National Safety ... lacking a comprehensive, proven plan to eliminate prescription opioid overdoses. ... how states are tackling the worst drug crisis in recorded U.S. ... Kentucky , New Mexico , ... Of the 28 failing states, three – Michigan ...
(Date:6/23/2016)... DUBLIN , June 23, 2016 ... "Global MEMS Devices Medical Market Analysis 2016 - Forecast to ... The report contains up to date financial ... reliable analysis. Assessment of major trends with potential impact on ... dive analysis of market segmentation which comprises of sub markets, ...
(Date:6/23/2016)... Research and Markets has announced the addition of the ... offering. The current unmet ... for MedImmune to enter. The US ageing population creates a ... considerable growth for effective anti-influenza medications. The introduction of a ... development is still in its infancy. Key ...
Breaking Medicine Technology:
(Date:6/27/2016)... ... June 27, 2016 , ... TherapySites, ... today its affiliation with Tennessee Counseling Association. This new relationship allows ... the Tennessee Counseling Association, adding exclusive benefits and promotional offers. , "TCA is ...
(Date:6/26/2016)... ... June 26, 2016 , ... On June 10-11, 2016, A Forever Recovery, a ... and World’s Longest Breakfast Table in Battle Creek, MI, where the rehabilitation facility is ... to some of the world’s leading providers of cereal and other breakfast foods. Its ...
(Date:6/25/2016)... ... 25, 2016 , ... Experts from the American Institutes for ... Meeting June 26-28, 2016, at the Hynes Convention Center in Boston. , AIR ... care planning, healthcare costs and patient and family engagement. , AIR researchers will ...
(Date:6/25/2016)... ... ... As a lifelong Southern Californian, Dr. Omkar Marathe earned his Bachelors in ... School of Medicine at UCLA. He trained in Internal Medicine at Scripps Green Hospital ... at the UCLA-Olive View-Cedars Sinai program where he had the opportunity to train in ...
(Date:6/24/2016)... ... June 24, 2016 , ... Those who have experienced traumatic events may suffer ... unhealthy avenues, such as drug or alcohol abuse, as a coping mechanism. To avoid ... healthy coping following a traumatic event. , Trauma sufferers tend to feel a range ...
Breaking Medicine News(10 mins):