FDA drug reviewers are questioning the benefits of Avastin, a cancer drug by Roche, saying that studies show it does not extend lives of breast cancer patients and does not reduce tumors as much as previously thought.
The FDA’s Avastin findings were included in a briefing document submitted to the agency’s Oncologic Drugs Advisory Committee, which will meet on Tuesday to make recommendations on whether Avastin breast cancer use should continue or whether there should be an Avastin recall for that approved treatment. In the briefing document, FDA reviewers said that not only were benefits in question, but the side effects of Avastin were more severe than with other, similar, drugs.
Avastin (bevacizumab) was approved by the FDA in 2004 for treatment of non-small cell lung cancer and colorectal cancer when combined with chemotherapy. It was then was granted accelerated approval for use with paclitaxel to treat breast cancer patients by FDA in February 2008. The drug prevents the formation of new blood vessels in tumors, starving them and inhibiting their growth.
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Learn MoreThe approval of Avastin for breast cancer treatment was based on a clinical trial finding that it slowed the growth of breast cancer tumors, at odds with the usual requirement that breast cancer treatment drugs show that they actually extend the lives of patients. As part of the accelerated approval process, Genentech, a subsidiary of Roche, had to continue two more drug trials and then submit their findings to FDA.
Now the FDA is indicating that follow-up studies seem to indicate that the drug does not extend patient lives, and also point out that the studies do not show the same amount of tumor growth reduction as the first trials. The new trials found that the most common of the severe Avastin side effects were hypertension, gastrointestinal bleeding and febrile neutropenia.
Avastin has also been tied to increased risk of blood clots and has been linked to reports of serious eye inflammation from Avastin when used off-label to treat wet macular degeneration.
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7 Comments
phillipApril 13, 2011 at 10:40 pm
sandy sory to you for the loss of you husban i lost my wife to brain cancer . she was giving avastin cpt 11 .she developed blood clots in feet and legs .after just 1 treatment. the clots spread to hips back lungs .she developed punture bleedin of the brain . she died after 6 treatment. she had no quailty of life after avastin .avastin is a dangerous drug.
BarbaraNovember 8, 2010 at 6:37 pm
I have Ovarian Cancer and as others have asked I was wondering if results were studied for Ovarian cancer patients. I just finished 6 treatments of Chemo with advastin added to the treatments. I have had no side effects I am aware of. Now I am getting ready to start a maintance treatment of just the avastin for 15 treatments. one every 3 weeks... My CA 125 # have went down and am anxious to see if[Show More]I have Ovarian Cancer and as others have asked I was wondering if results were studied for Ovarian cancer patients. I just finished 6 treatments of Chemo with advastin added to the treatments. I have had no side effects I am aware of. Now I am getting ready to start a maintance treatment of just the avastin for 15 treatments. one every 3 weeks... My CA 125 # have went down and am anxious to see if they stay down... I don't know if that is the result of adding avastin or if the 2 Chemo drugs are responsible for bringing the #'s down... but I guess I will continue with the avastin... at least till I find out something positive.
SandySeptember 1, 2010 at 6:27 pm
My husband was diagnosed in May of '08 with a grade 3 astrocytoma. His first surgery was successful in removing the entire 5cm tumor and then had 6 weeks of radiation and chemo with Temodar. Unfortunately it came back and was prescribed Avastin along with Temodar. He had another surgery and 75 to 80% was removed. We were very hopeful that the Avastin would help but the tumor within approx. 6 weeks[Show More]My husband was diagnosed in May of '08 with a grade 3 astrocytoma. His first surgery was successful in removing the entire 5cm tumor and then had 6 weeks of radiation and chemo with Temodar. Unfortunately it came back and was prescribed Avastin along with Temodar. He had another surgery and 75 to 80% was removed. We were very hopeful that the Avastin would help but the tumor within approx. 6 weeks of starting treatment had grew rapidly to the point it had doubled in size of the original and had spread toward the back of his brain. The surgeon and oncologist told us treatments were not working and basically sent him home to die. We were however referred to UAB where he endured yet another surgery was there for 2 wks with complications. After he came home he died in less than a month. The last weekend of his life was filled with seizures and loss of movement and speech. What was to have been a miracle drug for us turned out to not be true and I would hate for anyone else have to be told a drug will do this when it doesn't. I'm not for avastin to be pulled off the market as it does help some, but I think it should go under further studies and tests before making any more claims. My husband was 43 when he died and at 38, I am a widow with a daughter to raise without him.
JaimeJuly 31, 2010 at 2:52 pm
So who's the company funding the FDA inspection? Seems to be some more work of the "finding numbers" club. People die from cancer (known fact), this drug has given individuals an opportunity of efficacy and in some cases; remission. What the FDA is doing is working under a loaded gun. unfortunately, there have been some deaths associated with the drug but there have been more lives saved. If Avas[Show More]So who's the company funding the FDA inspection? Seems to be some more work of the "finding numbers" club. People die from cancer (known fact), this drug has given individuals an opportunity of efficacy and in some cases; remission. What the FDA is doing is working under a loaded gun. unfortunately, there have been some deaths associated with the drug but there have been more lives saved. If Avastin gets pulled off the market, the small amount of hope for patients is lost; I can assure you this drug works!
EdtithJuly 24, 2010 at 12:41 am
I was diagnosed with Dreaded Triple Negative Breast Cancer, (non hormone driven), which my Oncologist described as an aggressive form of Breast Cancer. I just finished 52 weekly Avastin/Taxol and am now taking 26 more bi-weekly treatments as a precaution. During the past year and a half, all of my scans have come back clean. My Oncologist feels that in my case Avastin combined with the Taxol h[Show More]I was diagnosed with Dreaded Triple Negative Breast Cancer, (non hormone driven), which my Oncologist described as an aggressive form of Breast Cancer. I just finished 52 weekly Avastin/Taxol and am now taking 26 more bi-weekly treatments as a precaution. During the past year and a half, all of my scans have come back clean. My Oncologist feels that in my case Avastin combined with the Taxol has definitely helped me. My question is, was the Dreaded Triple Negative type included in the clinical studies
C FrenJuly 22, 2010 at 7:28 pm
I have been treated for breast cancer with the combination of Chemotheraphy and Avastin. In April I was found to be cancer free. I had very few side effects from the Avastin, my blood pressure sometimes was high but nothing alarming. Maybe I was one of the lucky ones, but I would hate to see this medication taken off the market, because it does work!!!
bethJuly 21, 2010 at 12:37 am
My husband takes it for brain cancer. with the new findings on breast cancer are there any facts for this kind of cancer?