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:8/18/2017)... ... August 18, 2017 , ... ... specialized asset-light logistics provider of complex transport solutions for mission-critical and non-discretionary ... Unitrans International Corporation, a division of Roadrunner Transportation Systems, Inc. (NYSE: RRTS). ...
(Date:8/18/2017)... ... August 18, 2017 , ... ... devices. Through an educational webinar, they will present the line of epMotion automated ... learn how easy you can automate everyday pipetting tasks. , Ideal for scientists ...
(Date:8/18/2017)... Woodlands, TX (PRWEB) , ... August 18, 2017 ... ... protection assistance and financial planning services to communities in east Texas, is launching ... Pediatric Brain Tumor Foundation. , Founded in 1991, the Pediatric Brain Tumor Foundation ...
(Date:8/18/2017)... (PRWEB) , ... August 18, 2017 , ... The Golseth ... in the Dallas/Fort Worth area, is spearheading a regional charity campaign organized to provide ... , In early June of this year, Christina and her children returned from out ...
(Date:8/18/2017)... ... August 18, 2017 , ... Alcovit, a lime-flavored beverage that rids the body ... with its product now available through Jet.com. , After 25 years of development, ... drink is designed to quickly detox the body thereby avoiding alcohol-induced hangovers. Whether you’re ...
Breaking Medicine News(10 mins):
(Date:8/7/2017)...  Endo International plc (NASDAQ: ENDP ) ... all known U.S. mesh product liability claims and that ... remaining U.S. claims at reasonable values. Under the agreements, ... quarter of 2017 and continuing through the fourth quarter ... results, the Company intends to increase its mesh product ...
(Date:8/2/2017)... AROMAS, Calif. , Aug. 2, 2017 /PRNewswire/ ... by Continental Who,s Who as a Pinnacle Lifetime ... currently the Key Account Manager at Turing Pharmaceuticals, ... communications, negotiations, troubleshooting and relationship building.                ... has more than 25 years of experience ...
(Date:8/1/2017)... Aug. 1, 2017   CerSci Therapeutics , a ... Texas , has received notice from the National ... of Health (NIH) that it has been awarded a ... over $650,000 in 2017 with an additional $1,000,000 to ... New Drug application of their lead non-opioid drug candidate ...
Breaking Medicine Technology: