Navigation Links
FDA Approves New Indication for Afinitor
Date:11/1/2010

SILVER SPRING, Md., Nov. 1, 2010 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration approved the cancer drug Afinitor (everolimus) on Friday to treat patients with subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis (TS), a rare genetic disorder. This approval was for treatments of SEGA that can not be treated with surgery.

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

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

TS causes benign (non-cancerous) tumors to grow in the brain and in other parts of the body including the eyes, lungs, liver, heart, skin and kidneys. TS occurs as a result of genetic mutations that lead to the development of tumors and results in a variety of possible symptoms including learning and developmental disabilities, skin abnormalities, seizures, and lung and kidney disease.

SEGAs are considered a major diagnostic feature of TS and are slow growing tumors, seen in 6 percent to 9 percent of patients. The disease can be fatal for patients who develop complications with tumor growth on the brain. Surgery is used to remove the tumor growths in some patients.

"Patients with this disease currently have limited treatment options beyond surgical intervention," said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA's Center for Drug Evaluation and Research. "It is important for research to continue in rare diseases where patients have few or no existing drug treatment options."

The drug was approved under the FDA's accelerated approval program. The program allows the FDA to approve a drug to treat serious diseases with an unmet medical need based on an endpoint thought to reasonably predict clinical benefit. The company is required to collect additional long term efficacy and saf
'/>"/>

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

Page: 1 2 3

Related medicine technology :

1. FDA Approves Teflaro for Bacterial Infections
2. FDA Approves Latuda to Treat Schizophrenia in Adults
3. FDA Approves Additional Medical Indication for Sprycel
4. FDA Approves Pradaxa, Marking a Major Milestone to Reduce the Risk of Stroke in Patients with Non-Valvular Atrial Fibrillation
5. FDA Approves Pradaxa to Prevent Stroke in People With Atrial Fibrillation
6. FDA Approves Botox to Treat Chronic Migraine
7. FDA Approves Injectable Drug to Treat Opioid-Dependent Patients
8. FDA Approves Pharmaxis ARIDOL™ (Mannitol Inhalation Powder) Bronchial Challenge Test Kit for the Assessment of Bronchial Hyperresponsiveness
9. FDA Approves Combination Contraceptive Containing a Folate
10. U.S. FDA Approves New Oral Contraceptive That Also Raises Folate Levels
11. FDA Approves NDA That Includes Psychiatric Data Collected by Centralized Raters
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/25/2014)... ALBANY, New York , July 25, 2014 /PRNewswire/ ... published by Transparency Market Research "Global and China Insulin ... Insulin) - Industry Analysis, Size, Share, Growth, Trends and ... insulin market was valued at USD 19.99 billion in ... of 6.1% from 2013 to 2019 to reach USD ...
(Date:7/25/2014)... July 25, 2014  IDEXX Laboratories, Inc. (NASDAQ: ... second quarter of 2014 increased 11% versus the prior ... for the second quarter of 2014 versus the ... changes in distributor inventory 2 . Earnings per diluted ... increased 11% from the prior year period to $1.10."In ...
(Date:7/25/2014)... Leading events organizer UBM Live announces ... seventh year to São Paulo, Brazil ... The event will co-locate with Food Ingredients South America (FiSA), ... point for the pharmaceutical industry.      (Logo: http://photos.prnewswire.com/prnh/20130723/629764-a) ... sales are now exploring the South America ...
Breaking Medicine Technology:Global Insulin Market Expected to Reach USD 32.24 Billion Globally in 2019: Transparency Market Research 2Global Insulin Market Expected to Reach USD 32.24 Billion Globally in 2019: Transparency Market Research 3Global Insulin Market Expected to Reach USD 32.24 Billion Globally in 2019: Transparency Market Research 4IDEXX Laboratories Announces Second Quarter Results 2IDEXX Laboratories Announces Second Quarter Results 3IDEXX Laboratories Announces Second Quarter Results 4IDEXX Laboratories Announces Second Quarter Results 5IDEXX Laboratories Announces Second Quarter Results 6IDEXX Laboratories Announces Second Quarter Results 7IDEXX Laboratories Announces Second Quarter Results 8IDEXX Laboratories Announces Second Quarter Results 9IDEXX Laboratories Announces Second Quarter Results 10IDEXX Laboratories Announces Second Quarter Results 11IDEXX Laboratories Announces Second Quarter Results 12IDEXX Laboratories Announces Second Quarter Results 13IDEXX Laboratories Announces Second Quarter Results 14IDEXX Laboratories Announces Second Quarter Results 15IDEXX Laboratories Announces Second Quarter Results 16IDEXX Laboratories Announces Second Quarter Results 17IDEXX Laboratories Announces Second Quarter Results 18IDEXX Laboratories Announces Second Quarter Results 19IDEXX Laboratories Announces Second Quarter Results 20IDEXX Laboratories Announces Second Quarter Results 21IDEXX Laboratories Announces Second Quarter Results 22IDEXX Laboratories Announces Second Quarter Results 23IDEXX Laboratories Announces Second Quarter Results 24IDEXX Laboratories Announces Second Quarter Results 25IDEXX Laboratories Announces Second Quarter Results 26IDEXX Laboratories Announces Second Quarter Results 27IDEXX Laboratories Announces Second Quarter Results 28IDEXX Laboratories Announces Second Quarter Results 29IDEXX Laboratories Announces Second Quarter Results 30IDEXX Laboratories Announces Second Quarter Results 31IDEXX Laboratories Announces Second Quarter Results 32IDEXX Laboratories Announces Second Quarter Results 33
(Date:7/25/2014)... 25, 2014 As thousands of transvaginal ... courts, Bernstein Liebhard LLP notes that the Food & ... consumer advocacy group, Public Citizen, to order a global ... dated May 1, 2014, and released to the public ... for a ban on the marketing of all surgical ...
(Date:7/25/2014)... 2014 (HealthDay News) -- Babies seem to learn even ... the time women are 34 weeks pregnant, their unborn ... voice reciting a familiar nursery rhyme, the researchers report. ... sensory stimulation in the developing fetus," Charlene Krueger, nursing ... College of Nursing, said in a university news release. ...
(Date:7/25/2014)... vulnerable neurons and reduce motor deficits in a ... University School of Medicine have shown. , The ... Parkinson,s Disease . , The findings demonstrate that ... at sufficient levels and have beneficial effects when ... Previous studies of XPro1595 in animals tested more ...
(Date:7/25/2014)... American Society of Anesthesiologists (ASA) today announced the ... Learning Collaborative, a national initiative designed to improve ... More than 40 leading health care organizations ... collaborative, which will convene for the first time ... 25-26, in Schaumburg, Ill. , The PSH collaborative ...
(Date:7/25/2014)... 2014 Parkulture is proud ... and parkour instructor, Jared “JJ” Woods, will be competing ... American Ninja Warrior. The show will premiere on local ... will rerun on the new Esquire Network on Tuesday, ... resident, has been balancing careers as a professional stuntman ...
Breaking Medicine News(10 mins):Health News:Transvaginal Mesh Lawsuit News: FDA Rejects Petition Seeking Ban and Global Recall of All Transvaginal Mesh Products, Bernstein Liebhard LLP Reports 2Health News:Transvaginal Mesh Lawsuit News: FDA Rejects Petition Seeking Ban and Global Recall of All Transvaginal Mesh Products, Bernstein Liebhard LLP Reports 3Health News:Transvaginal Mesh Lawsuit News: FDA Rejects Petition Seeking Ban and Global Recall of All Transvaginal Mesh Products, Bernstein Liebhard LLP Reports 4Health News:Rhymes Reveal Evidence of Learning in the Womb 2Health News:Anti-inflammatory drug can prevent neuron loss in Parkinson's model 2Health News:ASA launches national Perioperative Surgical Home learning collaborative 2Health News:ASA launches national Perioperative Surgical Home learning collaborative 3Health News:Jared “JJ” Woods Prepares for American Ninja Warrior City Finals 2Health News:Jared “JJ” Woods Prepares for American Ninja Warrior City Finals 3
... Td-Vac priced at Rs. 7.50 has been launched by Serum ... aimed at combating the fatal tetanus and diphtheria (Td) in ... existing dual antigen vaccine used in children and would be ... administered following injury. ,The vaccine is regarded to ...
... which costs US$ 2,300 is used for heart diseases, and ... likely to result // in allergic reactions, the risks ... ,The Northwestern Memorial Hospital’s Dr. Charles Davidson has ... limited. The new drug-eluting stents are Cypher and Taxus. There ...
... been devised that can predict the potential attack of asthma.// ... help to asthmatics control their symptoms more effectively and improve the ... of an asthma attack occurring over the next month was made ... the model is the chaos model. The model the international team ...
... measure of how fast a person can exhale can now ... before a month using a mathematical tool. //It is believed ... patients and lead to the development of better treatment strategies. ... (currently applied to complex systems such as weather) has been ...
... Government promised in June last year that every patient referral ... 'choose and book' system by the end // of this ... the latest month for which figures are available - barely ... ,The Department of Health figures show that between October 2004 ...
... leading vaccine manufacturer Serum Institute of India has manufactured for ... // . ,The vaccine is called Td-Vac and ... and adults. The new vaccine will replace the existing TT ... ,Td-Vac is priced at Rs 7.50 whereas the TT vaccine ...
Cached Medicine News:Health News:Mathematical Model Can Now Help Predict Asthma Risk 2Health News:GP's online referral scheme in UK 'a national IT disaster' 2
... Ordering/Dispensing has gained recognition as the industry ... system. It enables opticians to place instant ... electronic communications technology. When used in conjunction ... frame tracers, lens shapes are automatically transmitted ...
... complete practice and business management software ... and ophthalmologists- It is designed for ... graphically rich and intuitive windows interface ... features and functionality- The multi-user version ...
The K-4500 automated hematology analyzer offers fast reliable test results of 18-parameter plus 3-histograms, valuable for effective diagnosis....
The XT-2000i is a compact, high performance, automated hematology analyzer that provides accurate and precise CBC result including a fully automated WBC 5-part differential, and comprehensive test re...
Medicine Products: