Navigation Links
FDA Commissioner announces Avastin decision
Date:11/18/2011

day hearing held in June, 2011.

Avastin was approved for metastatic breast cancer in February 2008 under the FDA's accelerated approval program, which allows a drug to be approved based on data that are not sufficiently complete to permit full approval. The accelerated approval program provides earlier patient access to promising new drugs to treat serious or life-threatening conditions while confirmatory clinical trials are conducted. If the clinical trials do not justify the continued approval of the drug or a specific drug indication, the agency may revoke its approval. In this case, the accelerated approval was based on promising results from one study that suggested that the drug could provide a meaningful increase in the amount of time from when treatment is started until the tumor grows or the death of the patient.

After the accelerated approval of Avastin for breast cancer, the drug's sponsor, Genentech, completed two additional clinical trials and submitted the data from those studies to the FDA. These data showed only a small effect on tumor growth without evidence that patients lived any longer or had a better quality of life compared to taking standard chemotherapy alone – not enough to outweigh the risk of taking the drug.  

FDA's Center for Drug Evaluation and Research, which is responsible for the approval of this drug, ultimately concluded that the results of these additional studies did not justify continued approval and notified Genentech it was proposing to withdraw approval of the indication.  

Genentech did not agree with the Center's evaluation of the data and, following the procedures set out in FDA regulations, requested a hearing on the Center's withdrawal proposal, with a decision to be made by the Commissioner. That two-day hearing, which took place June 28-29, 2011, included recommendations from the FDA's Oncologic Drugs Advisory Committee (ODAC), voting 6-0 in favor of withdrawing approval of
'/>"/>

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

Page: 1 2 3

Related medicine technology :

1. New York City Mayor Bloomberg and Health Commissioner Farley Receive Flu Shot at Duane Reade Pharmacy, Highlight Importance of Flu Preparedness
2. FDA Commissioner Outlines Steps to Spur Biomedical Innovation, Improve Health of Americans
3. NORD Hosts Forum for FDA Commissioner and Patient Leaders
4. Former FDA Commissioner Joins Bexion Pharmaceuticals Board
5. AdvaMed 2010 Premier Medical Technology Conference Opens Today in Washington D.C. With Executive Workshops, Company Presentations, Innovation Alley Exhibits and Featured Keynote Speakers: FDA Commissioner Dr. Margaret Hamburg, CMS Administrator Dr.
6. Medical Device Conference Opens October 18, 2010 With Free Executive Workshops; Full Conference Highlights Latest Industry Trends, Technology Innovations and Keynote Speeches by the U.S. FDA Commissioner, U.S. CMS Administrator, CBS Evening News Anc
7. Qmed, the Leading Global MedTech Industry Resource Announces New Regulatory Tool to Streamline and Simplify the Regulatory and Product Development Process
8. EUSA Pharma Announces FDA Approval of Orphan Drug ERWINAZE™ for Treatment of Acute Lymphoblastic Leukemia
9. Nonin Medical Announces Launch of Worlds First and Only OEM Solution for Regional Oximetry at Medica Congress
10. Disposable Film Festival Health Announces 2011 Award Winners
11. Avanir Pharmaceuticals Announces EMA Acceptance of Marketing Authorization Application for NUEDEXTA
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/23/2014)... , July 23, 2014 UBM Medica ... – a new online community and information resource for ... manage and treat their patients with neurological disorders ... with an aging population, necessitates greater access to dedicated ...  Key statistics on neurological conditions include: , ...
(Date:7/23/2014)... Calif. , July 23, 2014 Pharmavite ... the company,s chief customer officer effective immediately. Toll recently ... customer sales and marketing, category management, private label and ... . In his new global role, Toll will expand ... global sales planning. "Toll,s appointment to chief ...
(Date:7/23/2014)... Research and Markets   has ... Ablation Catheters Market 2014-2018" report to their ... Catheter ablation is a minimally invasive ... pathways from sections of the heart that promote ... Cardiac arrhythmias can be of several types, including ...
Breaking Medicine Technology:UBM Medica US Launches NeurologyTimes.com 2UBM Medica US Launches NeurologyTimes.com 3Global Electrophysiology Ablation Catheters Market 2014-2018: Key Vendors are Boston Scientific, Johnson & Johnson, Medtronic and St. Jude Medical 2Global Electrophysiology Ablation Catheters Market 2014-2018: Key Vendors are Boston Scientific, Johnson & Johnson, Medtronic and St. Jude Medical 3
... 2011 Amgen (NASDAQ: AMGN ) reported total ... to $3,959 million versus $3,804 million in the second quarter ... second quarter of 2011 to $3,893 million versus $3,613 million ... revenue in the second quarter of 2011 included a decline ...
... ENCINITAS, Calif., July 28, 2011 /PRNewswire-iReach/ -- Encinitas, CA-based ... the 2011 season in full focus with today,s launch of their ... E N invites the World Wide Web to explore art, culture, ...   http://photos.prnewswire.com/prnh/20110728/CG43745 ) THE LOOK ...
Cached Medicine Technology:Amgen’s Second Quarter 2011 Revenue Increased 4 Percent to $4.0 Billion 2Amgen’s Second Quarter 2011 Revenue Increased 4 Percent to $4.0 Billion 3Amgen’s Second Quarter 2011 Revenue Increased 4 Percent to $4.0 Billion 4Amgen’s Second Quarter 2011 Revenue Increased 4 Percent to $4.0 Billion 5Amgen’s Second Quarter 2011 Revenue Increased 4 Percent to $4.0 Billion 6Amgen’s Second Quarter 2011 Revenue Increased 4 Percent to $4.0 Billion 7Amgen’s Second Quarter 2011 Revenue Increased 4 Percent to $4.0 Billion 8Amgen’s Second Quarter 2011 Revenue Increased 4 Percent to $4.0 Billion 9Amgen’s Second Quarter 2011 Revenue Increased 4 Percent to $4.0 Billion 10Amgen’s Second Quarter 2011 Revenue Increased 4 Percent to $4.0 Billion 11Amgen’s Second Quarter 2011 Revenue Increased 4 Percent to $4.0 Billion 12Amgen’s Second Quarter 2011 Revenue Increased 4 Percent to $4.0 Billion 13Amgen’s Second Quarter 2011 Revenue Increased 4 Percent to $4.0 Billion 14Amgen’s Second Quarter 2011 Revenue Increased 4 Percent to $4.0 Billion 15Amgen’s Second Quarter 2011 Revenue Increased 4 Percent to $4.0 Billion 16Amgen’s Second Quarter 2011 Revenue Increased 4 Percent to $4.0 Billion 17Amgen’s Second Quarter 2011 Revenue Increased 4 Percent to $4.0 Billion 18Amgen’s Second Quarter 2011 Revenue Increased 4 Percent to $4.0 Billion 19R A E N Optics Launches New Website and Releases New Styles 2
(Date:7/24/2014)... 2014 Crawford Technologies today announced ... partnership with AIIM, focusing on global trends in ... of the survey indicated that even though organizations ... for customer service, legal and regulatory compliance and ... save exact facsimiles of these documents. , The ...
(Date:7/24/2014)... Freeslate, Inc ., the leading ... development, today announced its feature in the BioProcess ... Kling. Topics of this article include problematic ... automation can help address many of these problems. ... a growing focus of pharmaceutical organizations in recent ...
(Date:7/24/2014)... NE and Ft. Lauderdale, FL (PRWEB) July 24, ... an agreement to provide a wide range of ... nationwide. Under the agreement, BMG member practices can ... , “Blackmaple GroupPurchasing Solutions is growing rapidly, building ... Cooper, Partner. “Our approach is to offer deep ...
(Date:7/23/2014)... (PRWEB) July 23, 2014 The discounts ... and beauty products do not include various skin creams ... now revealing skin tightening cream discounts inside of its ... The guide is now available to offer a direct ... recently released products available for sale. Although the guide ...
(Date:7/23/2014)... The age spots, wrinkles and puffy eyes that can be ... now explored in a new guide posted at the Cherry ... over 30 are introduced in the guide as well as ... of creams as an alternative to surgery is one method ... the information in the new guide. Because there are hundreds ...
Breaking Medicine News(10 mins):Health News:AIIM Research Shows 56% of Organizations Not Utilizing Digital Archiving Technology 2Health News:AIIM Research Shows 56% of Organizations Not Utilizing Digital Archiving Technology 3Health News:AIIM Research Shows 56% of Organizations Not Utilizing Digital Archiving Technology 4Health News:Freeslate Featured in BioProcess International Article Discussing Challenges and Solutions to Highly Concentrated Protein Formulations 2Health News:Freeslate Featured in BioProcess International Article Discussing Challenges and Solutions to Highly Concentrated Protein Formulations 3Health News:Seacoast Medical Partners with Blackmaple Group to Provide Members Cost Savings on Wide Range of Pharmaceutical Products 2Health News:Skin Tightening Cream Discounts Revealed in New Cost Saving Guide at Consumer Portal 2Health News:Best Eye Creams for Women Over 30 Detailed in Published Guide at News Website Online 2
... Arunachal Pradesh have rediscovered a rare medicinal plant after more ... Botanical Survey of India spotted the wild flower, Begonia Tessaricarpa, ... northeastern state's Upper Subansari district bordering China. ... found the flower blooming in a narrow strip of rocky ...
... A three-day yagna-fire worship-with 1,000 pyres began Friday here to ... ,Amid chanting of Vedic hymns by Hindu priests from ... heads, the ritual was performed with the lighting of a ... Eastern Railway near here. ,The yagna, organised by ...
... are conducted periodically to check fitness in students. Jack ... year's results of the annual assessment of fifth, seventh ... the fifth, seventh and ninth graders and studies student ... the test this year. Only one-third could meet the ...
... been benefited by occupational therapy which helped them to ... //improving as well as helping their caregivers, according to ... hikes up costs of health-care and social services in ... of this disease. Besides, current drugs do not improve ...
... is causing eating disorders among several patients, according to ... Improvement Scotland (NHS QIS) added that the 'myths' available ... by thousands of Scots afflicted with conditions like anorexia ... have been issued by the health watch dog for ...
... fever has killed 44 people in Pakistan and forced nearly ... ministry, 4,866 people with symptoms similar to dengue fever have ... 1,724 of them have tested positive for the virus. ... and one in the North West Frontier province. ...
Cached Medicine News:Health News:Medicinal Plant Rediscovered After 115 Years 2Health News:Task therapy Beneficial to Patients with Dementia 2Health News:Internet Health Advice Causing More Harm than Good 2
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
Medicine Products: