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November 18th, 2011
02:03 PM ET
FDA rejects Avastin for use against metastatic breast cancerThe Food and Drug Administration announced Friday that it was revoking its approval of the drug Avastin for metastatic breast cancer after concluding that it has not been shown to be safe and effective for that use. "The FDA recognizes how hard it is for patients and their families to cope with metastatic breast cancer and how great a need there is for more effective treatments. But patients must have confidence that the drugs they take are both safe and effective for their intended use," said FDA Commissioner Margaret Hamburg, who made the announcement. “As a doctor, a woman and a parent, I know how frightening a diagnosis of metastatic breast cancer can be and the need for good treatment, but after reviewing the available studies," she said, there is no evidence that Avastin does "help women with metastatic breast cancer live longer or improve their quality of life." The FDA’s decision removes the use of Avastin in combination with the cancer drug paclitaxel for women who had not been treated with chemotherapy for the form of metastatic breast cancer known as HER2 negative. The removal is based on extensive records, which include thousands of pages submitted to a public docket, data from several clinical trials and the record from a two-day hearing in June 2011, as well testimony from a hearing on the drug held in December of last year. Avastin went through an accelerated approval process so it could go to women who needed treatment. After the approval, the drug's sponsor, Genentech, completed two additional clinical trials and submitted the data from those studies to the FDA. The data showed only a small effect on tumor growth without showing that patients lived any longer or had a better quality of life, compared with taking standard chemotherapy. “We found after rigorous testing the side effects of Avastin were more damaging than the benefits,” Hamburg said. Tests showed that side effects from the drug included bleeding, hemorrhaging, chance of heart failure or heart attack and high blood pressure, as well as perforation of the body, including the stomach, nose and intestines. Although the drug has been deemed “unsafe,” many women on Avastin swear by it and say it has made a difference in their lives. Although Avastin will still be available once the FDA removes the approval, it will no longer be covered by insurance for use against breast cancer, and that’s a main concern with patients. “The FDA doesn’t regulate the practice of medicine,” Hamburg said. “It is up to a patient and doctor to discuss the risks and benefits." In a written response, Genentech said, “We are disappointed with this outcome. We remain committed to the many women with this incurable disease and will continue to provide help through our patient support programs to those who may be facing obstacles to receiving their treatment.” The statement continued, “Despite today’s action, we will start a new Phase III study of Avastin in combination with paclitaxel in previously untreated metastatic breast cancer and will evaluate a potential biomarker that may help identify which people might derive a more substantial benefit from Avastin.” When asked if the FDA would reconsider Avastin for metastatic breast cancer if more tests from Genentech found it to be safe and effective, Hamburg was open to discussion. “We will work with Genentech on this issue,” she said. “But for now, this is our decision.” Avastin will still remain on the market as an approved treatment for certain types of colon, lung, kidney and brain cancers.
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Get a behind-the-scenes look at the latest stories from CNN Chief Medical Correspondent, Dr. Sanjay Gupta, Senior Medical Correspondent Elizabeth Cohen and the CNN Medical Unit producers. They'll share news and views on health and medical trends - info that will help you take better care of yourself and the people you love.
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Wasn't it just 6 months ago when the FDA said women should not get breast exams in their 30s? Science and popular belief are two different things.
NICE refused this from the word go.
The whole reason behind the FDA's approach to drug approval is to prevent dangerous substances from being marketed as safe. For those of you too young to remember; google 'thalidomide'. It was the FDA that prevented that terror from being marketed in the United States.
It was already approved by the FDA. Now, the FDA says that it made a mistake. It is being taken off the market because it is too expensive. This is the rationing everyone was talking about.
@ harvey, thalidomide was FDA approved in the late 90s but only with severe precautions. The S enantiomer of thalidomide is teratogenic...FYI
Too bad they were a little slow to react on the Vioxx I was prescribed at the VA, or the tainted heparin imported from China my spouse got a few years back after having a PE. Big Pharma has too much power in our system to market their drugs. The GOP wants free market and us being the guinea pigs! They're already under funded enough! During the evening news everyday probably 90% of the ads are marketing some pharmaceutical, especially if it's covered by Medicare!
this makes me so sad...a dear friend has lived much longer than expected as a result of this treatment.
Which could be the reason why thery're pulling it.
What about personalized medicine? Not there yet...no money for research but for war – any time!
PREVENTION is the key here. Stop taking estrogen (birth control pills and menopausal supplements) and start eating more fish and other iodine products. Also, stop eating all these chemicals in all of our foods, ingesting about 1 gallon of preservatives per year. (Read the labels and do the research. This isn't rocket science. Do the research for yourself. ) Doctors don't care about you...they're in it for the money. Once you're a cancer patient, they're putting another down payment on a new car for their spoiled brat.
Stage Right : The nutter enters.
It is interesting to watch the FDA rubber stamp the pharmaceutical industry, only to find out that these drugs cause more problems than they claim to cure. There just shouldn't be an accelerated approval process,
Avastin works for a minority and not for the majority; administering it to everyone while ignoring this fact in light of considerable side effects is inappropriate. These facts – not opinions – lead to the FDA's decision. Studies have indicated that a reliable biomarker might exist for determining that minority ahead of administration, so Genentech is seeking to prove that. If successful, that should pave the way for the minority who can benefit to get treatment in a predictable fashion.
Anything else would be a crime to those who cannot benefit, including those who spend tens of thousands for a placebo effect. The delay to resume treatment is sad, but necessary.
If you look at the statistics out there about prescription medication, anyone who would believe what a pharmaceutical or what a doctor says needs to rethink their position... The best prevention is to take care of yourself. Eat healthy, exercise, avoid seeing a doctor...
I saw this news report on TV last night, and I'll tell you I was very disturbed about it. What disturbed me was–even though I know they aren't all male physicians–that showed these male medical professionals, and I'm hearing them say that studies have shown that Avastin maybe didn't make that much of a difference, or always a difference, blah blah...........................guys, ever have breast cancer (I realize that some males can get it, but that it appears statistically to be more reported and diagnosed in women)...? How can they have the gall to say that, to people who have ever had, or who have cancer, or to their loved ones? ...Do you know or understand that "enough" or "not always" can make the differences between life and death for some people? Especially when the same drug being used for other kinds of body cancer isn't being pulled? Talk about wiping out hope for or creating desperateness in millions of patients. Our medical system, and its payment procedures, are really upside down in this country.
I see a lot of ignorant posts out here. Bevacizumab did not show any improvement in overall survival compared to the other treatment out there. Why would we pay over $100000 for something that just doesn't work? You can say "my wife lived longer on this med" but that is an inaccurate statement. You can't prove it. She would have lived that long with other options. Remember all cancers are different so just because it doesn't work for breast doesn't mean that it is ineffective for lung or colon. This med should have been removed years ago for breast...look at the evidence-based medicine.
re iodine–do NOT eat fish–full of mercury, pcb's, etc–also oceans need rest b/c of massive overfishing. So other sources of iodine: sea vegetables (v. high), organic strawberries, navy beans, yogurt, cranberries (happy Thanksgiving), and potatoes.
Well since this is the FDA we are talking about. This probably means the drug actually worked with limited side effects.
One has to wonder what, or who, was actually behind the approval in the first place. The FDA rides to our rescue once agaiin.
My wife was on Avastin for a few years for breast cancer; a clinical trial run by Dana Farber in Boston. It put her cancer in remission for 3 years. She passed away the day after my daughter's 12th birthday. Why doesn't the FDA tell my daughter those 3 years weren't important.
This drug is dangerous? what kind of logic the FDA use in their decisions? I understand if this was a drug for headache or minor illness. We are talking a killing disease here, how much more risk this drug can impose on patients than what nature has done to them. It's like telling someone who have all their heart artiries blocked that they can't get a bypass surgery because it is high risk. Helloooo, anybody there?
How about a DVT or GI perforation or hemorrhage? You could die from these a lot faster than metastatic breast.
"perforation of the body" enough said. yank it, and perforate whoever made the damn drug
The FDA giveth, the FDA taketh away.
Metastatic breast cancer is a form of cancer that starts in the breasts, and spreads to cause colon, lung, kidney and brain cancers. For the pharmaceutical industry to make money these cancers need to spread first - then be treated individually. Killing the source of colon, lung, kidney and brain cancers is effectively killing the goose that laid the golden egg.
Evan-that is incorrect. Metastatic breast cancer spreads to the colon, lungs, etc...but it is still breast cancer. You still treat it like breast cancer even if in the lungs.
I am a breast cancer survivor, 9 years and counting. The post treatment meds I was given put my whole system into overdrive and resulted in me losing my uterus and ovaries. I am cancer free, yes. But I often wonder if the drugs were better developed might I have have avoided the trauma of going into menopause at age 38? I am all for new treatments – especially for mestastic disease. But, perhaps segment it into those who are willing to try it for the sake of research and those for whom it is prescribed as an actual treatment. I urge caution in broadly prescribing meds, but laud all of those patients willing to help figure out if they really work.
I'm a 34 year old cancer survivor. Had lymphoma... The drugs and the treatments and the recovery that I went through were brutal. But, I survived... that is the point. I was willing to do anything to get through it and go back to living my life. I, at one point, took a new chemo drug that had me puking 10-15 times a day and a lot of other crazy side effects. But it killed a tumor and like I said, I survived. I think sometimes the FDA looks at this from the "big pharma lobbies the crap out of us, let's rush this drug to the public" POV, but at what point is the concern and wellfare of the patient the main focus? I have been in remission for over 3 years but the chance of getting cancer again will hang over those of us who have beaten this horrible disease once or multiple times for the rest of our lives. I would feel a lot better about having to trooper through life like that if I felt I could trust the big companies and big brother to do what is right for us patients. I am glad it is still, for the most part, a decision and a process that the Dr. and the patient go through and make all the decisions for. Every person is different and every cancer is different, even if they are diagnosed to be a certain kind every person reacts differently to the tumors and more importantly to the treatments. The chemo and radiation I went through kicked my butt but others who had similiar cancers had a much easier time dealing with the same treatments I got. Some reacted much more strongly and treatments had to be stopped. Thank god I was able to be treated at Moffitt Cancer Center in Tampa. They saved my life. Now, if we could only make it affordable for everyone to get world class cancer treatment and drugs. A persons life should never come down to whether or not they can afford treatment that is available that can save their life. We need to fix the insurance companies and the drug companies from holding most of us Americans hostage when it comes to expenisve life-saving treatments. Every single claim I made to my insurance company was systematically denied without being reviewed and it was only after I and the folks at Moffitt spent time on the phone arguing with them would they authorize treatments and treatment plans. My total cost to get me into remission: a little over $640,000 for a years worth of treatments, surgeries and hospital stays. Does anyone else see this as a problem as I do?...
We in healthcare know it is more profitable to treat cancer than cure it.
One breast cancer patient’s life saving therapy is another’s pulmonary embolism without clinical benefit. Until such time as cancer patients are selected for therapies predicated upon their own unique biology, we will confront one Avastin after another.
The solution to this problem is to investigate the VEGF targeting agents in each individual patient’s tissue culture, alone and in combination with other drugs, to gauge the likelihood that vascular targeting will favorably influence each patient’s outcome.
The Avastin saga is but one example of what will occur repeatedly. The one-size-fits-all paradigm is crumbling as individual patients with unique biological features confront the results of the blunt instrument of randomized clinical trials.
I think this is because Avastin has such a margin of error in dosage. But I am not a doctor, I'm a chemical engineer.
It's not totally possible to administer correctly without measuring the vasculature of a tumor, and by the time it's gone metastatic, who knows how to determine this. There are a ton of publications by R.K. Jain at Harvard Med school (who is a chemical engineer!) saying that you need to use Avastin to "Normalize" blood vessels in tumors, not completely destroy them. If you destroy the vessels completely two things can happen, 1. You destroy the vessels that carry chemo drugs to the tumor, and 2. The tumor becomes hypoxic, starved for oxygen, which makes it resistant to radiation treatment! If the blood vessels are "normalized" instead of destroyed using Avastin very delicately, then treatment is more effective. I hope Genentech re evaluates and determines a more precise dosing formula.
The way that you get responses to Avastin is by (temporarily) destroying the vasculature, not by normalizing blood vessels in tumors. What Jain is talking about is "pruning" the vasculature (it's just semantics). The problem is that the vessels grow back (quickly). The most vulnerable vessels (to Avastin) are the most newly formed, which are at the vanguard of the advancing tumor.
It is possible to correctly administer Avastin by measuring the vasculature of a tumor with an anti-angiogenesis microvascular viability assay called AngioRx. The test works by measuring drug effects upon endothelial cells which make up blood vessels. Its use could prolong lives, save money, and spare patients exposure to the harmful side-effects of ineffective chemotherapy treatments.
Today FDA approved BSD-2000 a medical device using hyperthermia to treat many types of cancers/tumors. Manufacturer – BSD Medical Corporation.
We are so focused on treatment and not prevention. It is a mentality embedded in Americans by big pharma and the healthcare industry which is a BUSINESS people! If you are a drug company, and you had 2 potential medications on hand, one which cures the problem, and the other which treats the problem's side effects, which one are you going to push on the consumer? The FDA is corrupt, and makes most of its money from fees from pharmaceutical companies. And the FDA also requires 2 trials with good results for a drug to be approved, but doesn't count the trials with ineffective and poor results! I could go on for hours about Big pharma and the FDA. Cancer should be curable by now!! Google Dr. Burzynski and the FDA. Google AMA corruption, google ACS corruption, google NCI corruption!!
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