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

By Amanda Gardner
HealthDay Reporter

THURSDAY, Dec. 16 (HealthDay News) -- Federal health officials on Thursday recommended revoking approval of the drug Avastin to fight breast cancer, citing the medication's poor performance in follow-up studies and its potential for serious side effects.

But the recommendation, announced by U.S. Food and Drug Administration (FDA) officials at a news conference, will not immediately affect breast cancer patients' access to the drug or limit use of the Avastin (bevacizumab) for advanced colon, lung, kidney and brain cancer.

Nevertheless, the decision could leave breast cancer patients who have responded well to the drug wondering what to do next.

"FDA has taken the first step to removing the breast cancer indication from the label of the cancer drug Avastin," Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research (CDER), announced at the news conference. "This is a first step in a process and will not have an immediate impact on use of Avastin or the drug's availability."

"Oncologists currently treating patients with Avastin should use medical judgment in deciding whether to continue treatment or explore other treatment options," she added.

The drug's maker, Genentech, has been notified of the recommendation in writing and now has 15 days to request a proceeding to dispute the FDA recommendation and present additional evidence. The company "has not agreed to remove the breast cancer indication voluntarily," the FDA noted in a statement released Thursday.

Some doctors expressed concern at the decision.

"This is a tough issue. There are women who have clearly responded to the treatment, [and] this is going to be a very difficult pill to swallow for those women," said Dr. Neil Spector, professor of medicine at Duke Cancer Institute in Durham, N.C.

"There's a very real possibility that there may be a subgroup of women that 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 terms of cancer recurrence -- but not overall survival -- and was contingent on further data to confirm the results.

Three subsequent studies failed to find an overall survival benefit and, in fact, showed less impressive improvements in survival involving no progression of cancer.

After reviewing all four studies, FDA concluded that "patients receiving Avastin did not live any longer than patients not treated with the drug and were at greater risk of severe side effects, some of which are unique to Avastin," Woodcock said.

"These include perforations of the nose, stomach and intestine, many of which can be life-threatening, as well as high blood pressure, heart attack or heart failure, wound-healing complications and organ damage or failure," she said.

More information

The U.S. National Cancer Institute has more on Avastin.

SOURCES: Neil Spector, M.D., professor of medicine, Duke Cancer Institute, Durham, N.C.; Dec. 16, 2010 teleconference with Janet Woodcock, M.D., director, U.S. Food and Drug Administration Center for Drug Evaluation and Research; Dec. 16, 2010, news release, Seattle Cancer Care Alliance


'/>"/>
Copyright©2010 ScoutNews,LLC.
All rights reserved  

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:12/8/2016)... MA (PRWEB) , ... December 08, 2016 , ... ... Workers Compensation Research Institute (WCRI) officially opened registration today for its 33rd ... Hotel in Boston, MA . , The theme of the conference is “Persistent ...
(Date:12/8/2016)... Pennsylvania (PRWEB) , ... December 08, 2016 , ... ... Duck Donuts Franchising Company LLC, announced the first national #QuackGivesBack campaign which ... , “This was our first franchise-wide Quack Gives Back initiative, ...
(Date:12/8/2016)... ... December 08, 2016 , ... ZyDoc , a New ... Conventional Data Capture Methods for Input to Electronic Health Records: A Comparative Usability ... the comparative usability study demonstrate that a dictation-based method (“NLP Entry”) using ZyDoc’s ...
(Date:12/8/2016)... ... December 08, 2016 , ... ... County, a Property owned by an affiliate of Seavest, has won a prestigious ... Medicine Southern Chester County ambulatory care center (ACC) was named “Best New Development, ...
(Date:12/8/2016)... ... December 08, 2016 , ... ... Medication Therapy Management (MTM), adherence, and other pharmacist-delivered patient care services, has announced ... counsel and Eric Hoessel to vice president of sales. , Litsinger joined ...
Breaking Medicine News(10 mins):
(Date:12/8/2016)... and Markets has announced the addition of the "Endodontic Supplies - Global ... , ... markets for Endodontic Supplies in US$ Thousand. The report provides separate comprehensive analytics ... Europe , Asia-Pacific , Latin ... are provided for the period 2015 through 2022. Also, a six-year historic analysis ...
(Date:12/8/2016)... Research and Markets has announced the addition of the ... Usability - Forecast to 2025" report to their offering. ... , , ... at a CAGR of around 3.2% from 2015 to 2025. Some ... in extracellular microelectrode arrays and intracellular microelectrodes, research in left-to-right shunt ...
(Date:12/8/2016)... -- A Mederi Therapeutics Inc . anunciou aprovação regulatória, pela CFDA, e lançamento ... do refluxo gastroesofágico (DRGE). Foto -  http://photos.prnewswire.com/prnh/20161207/446903 ... ... Stretta procedure performed and broadcast during the Chinese Congress of Digestive Endoscopy, by ... , , ...
Breaking Medicine Technology: