Navigation Links
FDA Panel Rejects Avastin for Breast Cancer
Date:6/30/2011

By Amanda Gardner
HealthDay Reporter

WEDNESDAY, June 29 (HealthDay News) -- The blockbuster cancer drug Avastin got soundly rejected late Wednesday as a treatment for metastatic breast cancer by a U.S. health advisory panel that found the medication was not effective and causes dangerous side effects.

By unanimous vote, the panelists rejected the drug maker's appeal of a U.S. Food and Drug Administration recommendation last December to revoke Avastin's approval for breast cancer. The FDA recommendation cited the medication's poor performance in follow-up studies and its potential for serious side effects.

The drug maker, Genentech, now owned by pharmaceutical giant Roche, was given an unusual two-day hearing this week before the six-member advisory group.

Tuesday's opening-day hearing was dominated by patients and physicians who argued, often emotionally, against the drug's revocation.

"For the patients and their supporters, it was the reality that many of them were alive and well with few symptoms, which they and their physicians attributed to the fact that Avastin had a significant treatment benefit for their breast cancer," blogged Dr. Len Lichtenfeld, Deputy Chief Medical Officer for the American Cancer Society, who attended the hearing.

But later in the day, he added, "the FDA told a different story. The data from clinical trials, after looking at thousands of patients treated with Avastin in addition to more standard chemotherapy, showed no meaningful clinical benefit. At one point, an FDA representative said that they were looking for only one trial that had some sort of benefit ... No such trial emerged, while the side effect risk was considerable."

On Wednesday, according to CNN, Dr. Sandra Horning, one of Genentech's top scientists, cited a February 2008 memo in which the head of the FDA's cancer drugs division made positive comments about the study that he had criticized on Tuesday. Genentech officials also defended E2100, the original study that formed the basis for the FDA's accelerated approval, and said there were no better treatments available for many women, CNN reported.

Lichtenfeld, at the end of the first day of hearings, outlined the dilemma. "Clearly, we are in a place where emotion meets science and the FDA's decision will prove to be a difficult one," he said in his blog.

The advisory panel's vote is non-binding, and FDA commissioner Margaret Hamburg will make a final ruling, the Associated Press reported.

The FDA's unusual step of scheduling another hearing on the drug underscored the difficulty of withdrawing approval of a cancer medication, the AP reported.

"It says to me that either they [the FDA] have gotten a great deal of negative feedback from various quarters, or there's some kind of internal disagreement within the agency," Dr. Gary Lyman, professor at the Duke Cancer Institute in North Carolina, told the news service. Lyman was part of the FDA advisory panel that voted 12-1 last year to revoke Avastin's approval as a breast cancer therapy.

The FDA's December recommendation did not immediately affect breast cancer patients' access to the drug or limit use of Avastin (bevacizumab) for advanced colon, lung, kidney and brain cancer.

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

Avastin was OK'd in 2008 for use in metastatic breast cancer in conjunction with chemotherapy under the FDA's accelerated approval program. Approval was based on a clinical trial of 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 showed less impressive improvements in survival involving no progression of cancer.

More information

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

SOURCES: Len Lichtenfeld, M.D., Deputy Chief Medical Officer, American Cancer Society; CNN; Associated Press


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

Related medicine news :

1. FDA Panels to Weigh Dosing Labels for Kids OTC Fever Relievers
2. FDA Panel Delays Action on Dyes Used in Foods
3. FDA Panel Examines Possible Links Between Food Dyes, ADHD
4. FDA Panel: Ban on Menthol Cigarettes Would Boost Health
5. Menthol Cigarettes Marketed as Healthier, FDA Panel Says
6. International panel revises McDonald Criteria for diagnosing multiple sclerosis
7. FDA Panel Recommends Testing of Electroshock Devices
8. FDA Panel Recommends Tougher Standards for External Defibrillators
9. AADR testifies to the FDA advisory panel on dental amalgam
10. FDA Panel Calls for Safety Review of Mercury in Dental Fillings
11. New Diet Pill Wins FDA Panels Backing
Post Your Comments:
*Name:
*Comment:
*Email:
Related Image:
FDA Panel Rejects Avastin  for Breast Cancer 
(Date:2/26/2017)... ... 26, 2017 , ... IndustryArchive.Org . is announcing a new way for ... will now only pay for B.A.N.T. quality sales leads based on the Sellers decision ... the new reality that B2B buyers are controlling the sales process via the Internet ...
(Date:2/26/2017)... Florida (PRWEB) , ... February 26, 2017 , ... ... (PD) patients after receiving cognitive rehabilitation, according to a study released today at ... known that cognitive rehabilitation programs are proven to be effective in improving cognitive ...
(Date:2/24/2017)... ... February 24, 2017 , ... HealthPostures, ... Go. Core benefits and advantages built into the home office sit stand solution ... and feel. Ability to gain the benefits embedded in the TaskMate Go are ...
(Date:2/24/2017)... (PRWEB) , ... February 24, 2017 , ... ... provides business development, education, networking and recognition opportunities as well as advocacy for ... Works in Holmdel, NJ on February 23. The Council's Innovation Forecast event ...
(Date:2/24/2017)... ... ... The Smart Machine Age is here, and it’s disrupting everything. Not only could ... in the United States may be taken over by technology in the next five ... steamrolls over colleagues is drawing to a close. Success will belong to those who ...
Breaking Medicine News(10 mins):
(Date:2/24/2017)... Research and Markets has announced the addition of the "Global ... report to their offering. ... The Global Wireless Health Market is poised to ... to reach approximately $330.5 billion by 2025. This industry ... segments on global as well as regional levels presented in the ...
(Date:2/24/2017)... , Feb. 24, 2017 Physician General Dr. ... and Alcohol Programs Jennifer Smith commended South ... training for and using naloxone, a life-saving overdose reversal ... , a recovery specialist and overdose survivor who was ... providers. "A significant part of fighting the ...
(Date:2/24/2017)... Report analyzes the worldwide markets for Endodontic Supplies in US$ ... Canada , Japan , ... Latin America , and Rest of World. ... through 2022. Also, a six-year historic analysis is provided for ... and secondary research. Company profiles are primarily based on public ...
Breaking Medicine Technology: