Navigation Links
FDA Advises Against Avastin as Treatment for Breast Cancer
Date:12/16/2010

are likely to respond to this," Spector said. "I don't think this will be the end from the standpoint of investigation and people trying to understand who that subpopulation is. It's just unfortunate that this will put a huge crimp in trying to figure that out."

Another expert, Dr. Julie Gralow, director of breast medical oncology at the Seattle Cancer Care Alliance (SCCA), called the FDA decision "disappointing."

"It is clear that some breast cancer patients derive substantial benefit from Avastin," Gralow, who is also professor in the Medical Oncology Division of the University of Washington School of Medicine, said in a SCAA press statement. "We don't know how to select those tumors or patients yet. It is looking like patient factors, not tumor factors, might be the best way to select those who benefit. To withhold this drug from all patients because some don't benefit is incorrect."

Doctors can continue to prescribe Avastin to patients "off-label," as they do other drugs. But it's unlikely that insurance companies will cover off-label use of the drug given its high price tag, Spector said. Avastin now costs more than $8,000 a month, according to published reports.

The FDA did not rule out the possibility that if Avastin is actually revoked, approval could be restored for certain subgroups of patients who may benefit.

"FDA is ready to work with Genentech on any proposals to conduct additional studies in metastatic breast cancer designed to identify responsive tumors," added Woodcock.

In making the announcement, the FDA predictably followed the recommendation of an advisory panel, which voted 12 to 1 last July to strike breast cancer from the approved uses listed on the Avastin label.

Avastin was okayed in 2008 for use in conjunction with chemotherapy under the FDA's accelerated approval program. Approval was based on one clinical trial in patients with metastatic HER2-negative breast cancer that found a benefit in t
'/>"/>

Copyright©2010 ScoutNews,LLC.
All rights reserved  

Page: 1 2 3

Related medicine news :

1. Cymetrix Board Member Recognized for Enhancing the Growth and Operations of the Companies He Advises
2. Keep Stress Off the Holiday Meal Menu, Expert Advises
3. Paxil Blocks Tamoxifen, Lowers Survival Odds Against Breast Cancer
4. NASBE Supports First Lady Michelle Obama in Fight Against Childhood Obesity
5. AMA Joins First Lady in Fight Against Childhood Obesity
6. The Alliance for a Healthier Generation Names Celtics Captain Paul Pierce National Athlete Spokesperson in the Fight Against Childhood Obesity
7. Tiny fruit fly could offer big clues in fight against obesity, researcher says
8. Compound shows promise against intractable heart failure
9. Businesses Rally Big Efforts to Benefit the Susan G. Komen Phoenix Affiliates Fight Against Breast Cancer
10. NSAIDs Wont Shield Against Skin Cancer
11. A Healthy Diet Remains Your Best Weapon Against the #1 Killer: Heart Disease
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Advises Against Avastin as Treatment for Breast  Cancer
(Date:1/22/2015)... Jolla, Calif. (PRWEB) January 22, 2015 ... Assemblymembers Susan Bonilla (D-Concord) and Kristin Olsen (R-Modesto) ... for their leadership in advancing biotechnology, biomedical science, ... Bonilla and Olsen each received the “2014 Life ...
(Date:1/22/2015)... Four years since the release of their debut ... the marriage of Avasa & Matthew Love – the duo are ... for release through White Swan Records on February 24, 2015. , ... sacred path available to all of us to walk out of ...
(Date:1/22/2015)... As interest in the value of spiritual ... worldwide, Rev. Eric J. Hall , president and CEO ... will be the keynote speaker on January 27 at an ... system. , The conference, “Hope and Resilience: Innovative and Interdisciplinary ...
(Date:1/22/2015)... 2015 Lower-Auto-Insurance.com has released a new blog post ... car for reducing the costs of an auto insurance policy ... able to get lower prices for their vehicle insurance policies. The ... in determining policy costs. Because of this, drivers should always ...
(Date:12/26/2014)... The US represents the largest market for ... GlobalData’s forecast estimates that sales of branded therapies were $2.23 ... the high incidence of the disease, high drug treatment rate, ... China. Increased sales of CRC therapies over the forecast period ...
Breaking Medicine News(10 mins):Health News:California Biomedical Community Honors Senator Holly Mitchell, Assemblymembers Susan Bonilla & Kristin Olsen 2Health News:California Biomedical Community Honors Senator Holly Mitchell, Assemblymembers Susan Bonilla & Kristin Olsen 3Health News:THE ROAD by Avasa & Matthew Love -- A New Album 2Health News:THE ROAD by Avasa & Matthew Love -- A New Album 3Health News:THE ROAD by Avasa & Matthew Love -- A New Album 4Health News:HealthCare Chaplaincy CEO to Keynote Spiritual Care Summit in Israel 2Health News:HealthCare Chaplaincy CEO to Keynote Spiritual Care Summit in Israel 3Health News:Driving Safe And Other Factors That Make Auto Insurance Affordable! 2Health News:US Colorectal Cancer Drug Market Analysis and Forecast to 2023 Report Available at ReportsnReports.com 2Health News:US Colorectal Cancer Drug Market Analysis and Forecast to 2023 Report Available at ReportsnReports.com 3Health News:US Colorectal Cancer Drug Market Analysis and Forecast to 2023 Report Available at ReportsnReports.com 4
... Haneef, the man from Bangalore in southern India, continues . ... a small act of indiscretion, it looks like. He had allowed ... players in the failed Glasgow bombing. ,Intercepted when he ... the Glasgow incident, Haneef has been seeing his hopes soar only ...
... can more than double the risk of developing kidney cancer ... is a repeated loss and gain of body weight due ... aged between 50 and 79 for almost eight years to ... waist size to those with the large waistlines. ...
... chain 'PizzaExpress' has been named the most vegan-friendly food chain ... by the animal rights group for its cheese-free pizzas, the ... organisations recognised by PETA for 'animal-friendly progress'. ... and the first restaurant was opened in Wardour Street in ...
... fast food joint in Miami, Florida . ,The ... revealed that she has been hooked to the idea of ... ,"That was part of my L.A. education - on Sundays ... (cars)... FatBurger was, like, the centrepiece for it all," Contactmusic ...
... Combining medicines with the right food could improve the ... costs of treating patients, experts say . ... Ezra Cohen, MD, have released their expert comments after ... with fatty food, rather than on an empty stomach, ...
... the Varanavasi Village Panchayat near Kanchipuram in Tamil Nadu ... . ,Aghast over an ever-increasing trend of ... to ban the entry and consumption of tobacco products. ... consuming tobacco products like cigarette and gutka. Hence, the ...
Cached Medicine News:Health News:Haneefs Visa Revoked by Australia 2Health News:Right Foods Could Improve Drug Effectiveness, Lower Drug Costs 2Health News:Village Panchayat in Tamil Nadu Bans Tobacco Consumption 2
(Date:1/22/2015)... Therapeutics Inc. (OTCQX:PVTTF; CSE:PVO), ("Pivotal" or the "Company"), a specialty ... disease and overall health is pleased to provide you with ... outlook for 2015 from the CEO, Mr. Eugene Bortoluzzi ... like to take this opportunity to share with you the ...
(Date:1/22/2015)... MINNEAPOLIS , Jan. 22, 2015  Bio-Techne Corporation (NASDAQ: ... launched Ella, the first member of the new Simple ... ProteinSimple brand.  This launch represents the re-branding of the ... The Simple Plex platform is a transformative immunoassay technology ...
(Date:1/22/2015)... 2015 Increasing sophistication among enterprise buyers of language ... in 2015, says Moravia CMO, Renato ... by market research firm Common Sense Advisory, 15 percent ... translation and localization needs. "From a language industry perspective, ...
Breaking Medicine Technology:Pivotal Therapeutics: Year in Review and CEO Update 2Pivotal Therapeutics: Year in Review and CEO Update 3Pivotal Therapeutics: Year in Review and CEO Update 4Pivotal Therapeutics: Year in Review and CEO Update 5Pivotal Therapeutics: Year in Review and CEO Update 6Pivotal Therapeutics: Year in Review and CEO Update 7Bio-Techne Launches Simple Plex Platform 2Bio-Techne Launches Simple Plex Platform 3Moravia Sees Single-Sourcing as Key Localization Trend in 2015 2
... introduces new high precision femtosecond laser technology ... opportunity to offer their patients a safer, ... creating the corneal flap. By using ... IntraLASIK software, surgeons may avoid the complications ...
... Teco Diagnostics manufactures fine urine chemistry ... urine chemistry reagent strips from start ... offer more economical prices compared to ... quality. Teco Diagnostics urine reagent strips ...
... Long term complications associated with diabetes ... the health and quality of life of ... costs. These complications are known to be ... The discovery that the level of haemoglobin ...
The Lifestream Plus Cholesterol Monitor provides you with a comprehensive tool to help you monitor your cholesterol as part of your wellness program....
Medicine Products: