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

ized 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 dat
'/>"/>

Copyright©2010 ScoutNews,LLC.
All rights reserved  

Page: 1 2 3

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:8/28/2014)... August 29, 2014 Recently, iFitDress.com, the ... new selection of chic bridesmaid dresses . Included ... items. In addition, all of them are provided at ... , iFitDress.com insists on offering fast and reliable delivery ... what they order in a short time. As is ...
(Date:8/28/2014)... August 28, 2014 Blood's Thicker Than Water ... money and family ties in the heart of the city. ... – a story about how disrespect caused two families to ... many streets. , The Yayo Boyz and the M.O.B. Boyz ... speechless and local onlookers in a silent terror. "Guerrilla," AKA ...
(Date:8/28/2014)... FL (PRWEB) August 28, 2014 Millennium ... use affecting users in the workplace. A recent ... Dependence (NCADD) states that drug abuse is costing ... who use or are addicted to drugs affect their ... activities carry over into the workplace, causing expensive problems ...
(Date:8/28/2014)... government plans its exit strategy from the war, now may ... providing health care to veterans, says a Perspective piece in ... simply go on doing more of the same is to ... cost and population structure pose in the longer run," said ... Clinical Practice, and David Auerbach, from the RAND Corporation, in ...
(Date:8/28/2014)... 2014 The Governor of Yucatán, Rolando ... at a press conference; this event is organized by ... of Economy through the National Microenterprise Financing Program ( ... to the 5th at the Convention Center Yucatan Siglo ... a great responsibility for Yucatan to host the 17th ...
Breaking Medicine News(10 mins):Health News:New Selection of Chic Bridesmaid Dresses Available at iFitDress.com 2Health News:Raymond E. Blake Releases Blood's Thicker Than Water, Based on a True Story 2Health News:Drug Use Causes Problems in the Workplace 2Health News:A VA exit strategy 2Health News:Governor of the State of Yucatan presents the 17th Microcredit Summit 2Health News:Governor of the State of Yucatan presents the 17th Microcredit Summit 3
... of the daughters of women who had been given DES, ... that exposure to the drug while in the womb (in ... risk of certain cancers and pre-cancerous conditions. The results of ... (NCI), part of the National Institutes of Health, and collaborators ...
... HealthDay Reporter , WEDNESDAY, Oct. 5 (HealthDay News) -- A ... to reduce relapse rates and disability progression, according to the ... drug, teriflunomide, is one of the few oral drugs that ... a good choice for many MS patients, researchers said. ...
... of young people with melanoma, a deadly form of skin ... of invasive disease than adults. The study, published online ... to be the first to compare disease spread in children ... between childhood and adult melanoma, the researchers say. ...
... Beach, Fla. The prognosis for patients with stage ... is poor, with only about 15 percent of patients ... new treatment strategies are being intensely studied, timely assessment ... today, Mitchell Machtay, MD, principal investigator of the ACRIN ...
... 5, 2011)Approximately 10-20 percent of prostate cancer patients have a ... factors that are used to evaluate the extent and aggressiveness ... the Prostate Specific Antigen Level (PSA), Gleason score (GS) ... However, men with a family history of prostate cancer ...
... 5, 2011 The Merck Childhood Asthma Network, ... in funding to implement the Community Healthcare for ... in five non-profit, Federally Qualified Health Centers. This ... to demonstrate how asthma management tools proven effective ...
Cached Medicine News:Health News:Women exposed to diethylstilbestrol in the womb face increased cancer risk 2Health News:Women exposed to diethylstilbestrol in the womb face increased cancer risk 3Health News:Experimental MS Drug Shows Promise 2Health News:Experimental MS Drug Shows Promise 3Health News:Invasive melanoma may be more likely in children than adults 2Health News:FDG-PET appears promising for predicting prognosis of patients with inoperable NSCLC 2Health News:More aggressive treatment not necessary for men with a family history of prostate cancer 2Health News:Childhood asthma non-profit invests millions in health centers to help children better manage asthma 2Health News:Childhood asthma non-profit invests millions in health centers to help children better manage asthma 3
(Date:8/28/2014)... , Aug. 28, 2014 Reportlinker.com ... is available in its catalogue: ... http://www.reportlinker.com/p02332847/Needle-Free-Delivery-Technology-and-Market-Forecast-2014-2024.html ... discover technological and commercial prospects What does ... market? Visiongain,s brand new report shows you ...
(Date:8/28/2014)... 2014 Pharmatech initiated enrollment for its ... game-changing method for matching cancer patients to cancer ... target specific cancers, disease staging, and genetic mutations ... cancer, in the first place. The challenge that ... not be well known to the patient or ...
(Date:8/28/2014)... , Aug. 28, 2014 Tianyin Pharmaceutical ... a pharmaceutical company that specializes in patented biopharmaceutical, ... active pharmaceutical ingredients (API) today updates the timeline ... Facility (QLF). The Company is ... dataset for China Food & Drug Administration,s (CFDA) ...
Breaking Medicine Technology:Needle-Free Delivery: Technology and Market Forecast 2014-2024 2Needle-Free Delivery: Technology and Market Forecast 2014-2024 3Needle-Free Delivery: Technology and Market Forecast 2014-2024 4Needle-Free Delivery: Technology and Market Forecast 2014-2024 5Needle-Free Delivery: Technology and Market Forecast 2014-2024 6Needle-Free Delivery: Technology and Market Forecast 2014-2024 7Needle-Free Delivery: Technology and Market Forecast 2014-2024 8Needle-Free Delivery: Technology and Market Forecast 2014-2024 9Needle-Free Delivery: Technology and Market Forecast 2014-2024 10Needle-Free Delivery: Technology and Market Forecast 2014-2024 11Needle-Free Delivery: Technology and Market Forecast 2014-2024 12Needle-Free Delivery: Technology and Market Forecast 2014-2024 13Needle-Free Delivery: Technology and Market Forecast 2014-2024 14Needle-Free Delivery: Technology and Market Forecast 2014-2024 15Needle-Free Delivery: Technology and Market Forecast 2014-2024 16Needle-Free Delivery: Technology and Market Forecast 2014-2024 17Needle-Free Delivery: Technology and Market Forecast 2014-2024 18Enrollment in Pharmatech's Revolutionary AccessPPM Program Launches 2TPI Submits Dataset for GMP Inspection at Qionglai Facility (QLF) 2
Inquire...
300 L, Racked, Filtered, Pre-sterilized, 96 tips/rack Recommended for 250 and 300 L pipettes....
... Aerosol barrier tips eliminate false signals ... designed and tested, Promega Barrier Tips ... with amplified nucleic acids (PCR(a)), radioactive ... forensic and serological specimens. , ,Promega ...
Diamond Filter Tips play a critical role in preventing aerosol-borne contamination. Also available sterilized (no need to autoclave) and certified free of detectable RNase, DNase, DNA, RNA, and prote...
Medicine Products: