FDA panel rejects arguments for cancer drug
June 29th, 2011
10:36 AM ET

FDA panel rejects arguments for cancer drug

An FDA advisory panel on Wednesday unanimously rejected arguments from Genentech that its controversial anti-cancer drug should continue as an approved therapy for advanced breast cancer.

In pointed comments, several members of the panel said the company had not demonstrated that Avastin could help breast cancer patients live longer, or improve their quality of life. They also pointed to significant side effects, including high blood pressure in many patients, and cases of hemorrhage and intestinal perforations. One panel member, Dr. Wyndham Wilson of the National Cancer Institute, said that given the data, prescribing Avastin to breast cancer patients would be akin to violating the physician’s oath of “first, do no harm.”

The final decision lies with FDA Commissioner Margaret Hamburg. Karen Riley, an FDA spokeswoman, said the official record will remain open for comment until July 28th, but beyond that, there is no timetable for a decision. While the vote is a blow to Genentech, and deeply disappointing to many of the patients who attended the hearing in support of Avastin, the drug’s status will remain, for now, unchanged. Whatever the commissioner decides, it will not affect the drug’s approval as a treatment for certain types of brain, lung, colon and kidney cancer.

Avastin received provisional approval as a breast cancer therapy in 2008, based on the results of a study known as E2100. Last year, the FDA's Center for Drug Evaluation and Research (CDER) recommended that approval be withdrawn, based on larger studies with less impressive results.

While approvals and withdrawals only become official with the Commissioner’s stamp, CDER’s opinion is usually the last word. In this case, Genentech filed an appeal for a new hearing.

The highly unusual hearing began on Tuesday, with more than two dozen patients telling their personal stories, to scattered applause, urging the panel to keep Avastin available. The debate is highly charged. Some patients have accused the FDA of letting Avastin’s high cost – as much as $88,000 for a year – cloud its judgment. By regulation, the agency is not permitted to consider cost when it evaluates the safety and effectiveness of any treatment.

Wednesday, Genentech officials defended their studies, saying that certain patients respond especially well and that side effects, while potentially serious, are no worse than with other breast cancer drugs. They pointed out that Avastin is an approved breast cancer therapy in Europe, and that the National Comprehensive Cancer Network – an influential coalition of cancer centers – also considers it a viable option. One senior scientist, Dr. Sandra Horning, told the panel that for many women with breast cancer, there are no better treatments available.

Horning also painted CDER officials as flip-floppers. At one point she noted a memo from February 2008 in which the head of the agency's cancer drugs division made positive comments about study results that he – and other CDER officials – had dismissed on Tuesday.

But the panel wasn’t swayed. In a series of 6-0 votes, they agreed that research shows minimal benefit from Avastin. None of the five studies presented showed patients on the drug actually living longer. “We can only ask patients to take on this risk [of side effects] when there is significant benefit,” said Natalie Compagni-Portis, the “patient representative” on the panel. The demonstrated improvement – on an average, several weeks before the tumor got worse – was not enough.

“This is an emotional issue," Portis said in explaining her vote. “Any amount of extra time is meaningful for patients. After E2100 there were many reasons to be hopeful. I think we all wanted Avastin to succeed. The reality is these studies we’re hearing about did not confirm that. These studies did not bear out this hope.”

The panel also rejected a request from Genentech to maintain the drug’s approval while further studies are done, to identify which patients might be “super-responders” or more susceptible to side effects.

In a statement after the vote, Genentech spokeswoman Charlotte Arnold said, “We are very disappointed by the committee’s recommendation and hope the Commissioner does not decide to remove an important medicine for women with this incurable disease who already have too few treatment options. We remain ready to collaborate with the FDA to find a solution that is in the best interest of patients who need Avastin.”

soundoff (245 Responses)

    Freedom of Access to Medicines (FAMEDS) is the only nonprofit leading the effort for the FDA to continue to allow Avastin to be on-label for 17,500 women w Metastatic Breast Cancer surviving on the drug. Please view our complete coverage of the Hearing: http://fameds.org/hearing

    June 29, 2011 at 12:23 | Report abuse | Reply
    • Joe

      When the FDA recalls a drug that WORKS. I can only mean that it was a CURE.

      June 29, 2011 at 19:42 | Report abuse |
    • Wendy

      I have been on Avastin and Letrozole for 12 weeks and the mass in my left breast is almost non-existent, and I no longer feel the lesions on my ribs, spine and hip. For them to deny this medicine should be a crime!! I can work and do all that I did before I found out in February that I have stage IV metastatic breast cancer, actually, I feel BETTER and can do more! Isn't quality of life important as well as longevity? If it is healing us, that means we WILL live longer! What part of this don't they understand?

      June 30, 2011 at 06:57 | Report abuse |
    • Lagos

      Thanks for taking the truth that the FDA is dysfunctional and blowing it out of proportion, Joe. We need more nuts in the world.

      June 30, 2011 at 09:27 | Report abuse |
    • muskateer

      Avastin gave my beautiful,stage 4 friend 14 quality months that she wouldn't have had otherwise......GOOD months.....not just surviving....enjoying life & the people that loved her.
      I went to a Living beyond Breast cancer conference & there were plenty of women there who were very grateful for Avastin.
      Nothing works for everyone. I do think this comes down to expense...& that is sad...& wrong.

      June 30, 2011 at 19:21 | Report abuse |
  2. spoo

    avastin was initially tested on a certain subgroup of breast cancer patients, who responded positively to the drug. trying to extend the use of avastin to all breast cancer patients is just a marketing strategy to improve profits from the drug and sacrificing the patients who don't have any chance for their cancers to respond to this drug but will suffer only the side effects. poeple need to understand that this is the same story for most drugs in the market, and the pharma industry knows how to play the game. the only line of patient defense is the FDA, lets make sure it only gets better at doing their job.

    June 29, 2011 at 18:01 | Report abuse | Reply
    • Bucktooth

      Go to naturalnews.com and getthe scoop on the FDA! They are crooks also!

      June 29, 2011 at 23:42 | Report abuse |
    • Wendy

      It is not a marketing strategy, it works! And it is important that women with metastatic breast cancer have the opportunity to use Avastin. I have only had three infusions, along with my anti-hormone therapy, and I feel better than I did before I found out about the cancer. My health has improved dramatically. It works so well, they need to continue marketing Avastin; this may be the miracle drug women have been waiting for all these years. They say incurable, but a women can live for years because of this medicine. We have finally gotten beyond the point of generic chemotherapy for all cancers, and have found something that works on specific cancers, wonderfully! What is bad about that?

      June 30, 2011 at 07:07 | Report abuse |
    • kate510

      The "subgroup" Avastin was tested in happens to be largest population of women with MBC–patients who are HER2-negative.

      There are confounders to gathering survival data in MBC–most especially the fact that women have mutliple lines of therapy during the course of their metastatic disease (median: 4). It becomes very difficult to determine a survival advantage for one specific drug in this context.

      June 30, 2011 at 13:33 | Report abuse |
    • Elizabeth

      How many "peers" on the FDA board who rejected this drug have stage IV cancer? How many are women?
      My husband takes this drug for colon cancer; his blood pressure is low, never affected. He does take a blood thinner to prevent clots. We are still hoping that he will be cured. But the best thing he is doing right now is prayer, visualization that the cancer is being killed, and Chi Gong, although with all the chemo drugs. It comes down to hope: every cancer patient needs hope. Take away a drug and you remove some of the hope. It is not comfort care if you hurt people's feelings.

      July 1, 2011 at 00:33 | Report abuse |
  3. Lynn

    What was the man to woman ratio of the panel that made this decision? If it were a male cancer, wonder if the ruling would have came down different? I suspect, yes it would have been different had it been a drug to possibly save a man's prostrate.

    June 29, 2011 at 19:30 | Report abuse | Reply
    • Lagos

      Thanks for your opinion. In the future, please try to back it up with evidence, observations, reasoning, etc as to form a coherent argument rather than just wasting your time and ours.

      June 30, 2011 at 09:28 | Report abuse |
    • Elizabeth

      Lagos, if you live in the United States, you would know the history. Here, often only men are used in drug tests. Because of the outcry, that changed some years ago, but I still hear of drugs that are only tested on men, even though those drugs are meant for everybody. Up until recently, the medical community didn't even know that women have different symptoms during a heart attack because of the men-only studies. Two family members have a non-cancer condition called "endometriosis." Millions of women have this condition, which causes permanent damage to abdominal organs, but there is very little research done, because this disease only affects women. Over and over again, we have seen this situation. Get your facts straight before you snidely judge people who are trying to be cured of terrible diseases.

      July 1, 2011 at 00:37 | Report abuse |
  4. cag31

    I still think more tests or trials need to be done with this drug. The side effects can be fatal to some.people

    June 29, 2011 at 20:05 | Report abuse | Reply
    • Wendy

      I am currently in a clinical trial for Avastin, and they were VERY thorough before putting me on it. I am tested and questioned regularly. True, not all women can be on it, but I am, and it is doing wonders, literally!

      June 30, 2011 at 07:19 | Report abuse |
    • Lagos

      I'm sorry, but there's hundreds of prescription drugs on the market with potentially fatal side effects.

      June 30, 2011 at 09:24 | Report abuse |
  5. For the Poor People

    This is a scam. Avastin simply is not as effective as $88,000 is worth to anyone rich or poor. Inhibiting VEGF-A does not DOES NOT cure any cancer cell. Many solid malignancies are hypoxic at the core (no blood circulation inside) anyways and this suffocation helps make a tumor immortal, not help it die. Yes there are those tumors that are in anaerobic resistance to apoptosis even in ample oxygen too. There are cells that respond to the cancer and the cancer cells. VEGF-A secretion by cells that respond to the cancer help contain it. VEGF-A secretion by cancer cells help feed it. Inhibiting VEGF will turn off all new blood vessel formation everywhere in the body, defeating blood circulation. Containing metastasis by inhibiting neoangeogenesis is important but is most certainly not the one and only mechanism involved in making cancer survivable. A person should not gamble her hard earned $88,000 on a 2 in 100 chance of bought time with an equal chance of fatal side effects. Personally, I would advise anyone against this very poor odds bet. A doctor can never predict how long a person with cancer will live no matter whether he or she be from Harvard, Stanford, Duke or wherever. How do they arrive at that prognosis?? To say that the drugs bought time for the patient as they are emaciated and poisoned to death is an absolute fraud, especially when that patient dies anyways. These greedy people should be shot between the eyes.

    June 29, 2011 at 23:10 | Report abuse | Reply
    • Wendy

      This is NOT a scam!! Do you have any idea how much YEARS of research cost to come up with these medicines? Do you not think someone's life is worth $88,000 a year. Human life is PRICELESS!! No, Avastin is not for ALL cancers, but the ones it is used for is having great success! I have metastatic breast cancer and have only received three infusions, tomorrow will be my fourth, and I can't tell you the changes!! My lesions no longer ache, like they are not there; the mass in my left breast has all but disappeared and it was huge and shape-altering, no longer! I am in a clinical trial for Avastin and I thank the Good Lord that I am because this may be just the medicine to save my life. Ask my husband, children and grandchildren what price tag they would put on my life? If I couldn't pay for it, they would all work together to find a way to pay for it. Money is NOT the issue. Someone doesn't want women living longer and that is why they do not want the FDA to put it's stamp of approval on it, but I tell you, I am living proof Avastin is worth every cent!!!! I feel better than I did before I found out about the cancer. I eat better, exercise more, and feel healthier all the way around. Before you call something a scam, do some research. Ask anyone who has been on Avastin for colorectal, metastatic breast, or other cancers Avastin works with if they could put a price tag on it! You obviously have been fortunate enough not to have a close loved one with cancer. Mine, they say is incurable, but Avastin just may change that.

      June 30, 2011 at 07:15 | Report abuse |
    • Lagos

      Excuse me, but please don't tell people that they shouldn't "gamble" their own money for fear of them losing it, if they won't be able to use it because they're DEAD.

      June 30, 2011 at 09:23 | Report abuse |
  6. Anthony

    I've seen this work for a large number of patients. I'm aware of the potentially catastrophic side effects, but have never seen that occur and statistically it is rare. In fact, Avastin is considerably more tolerable than almost all chemotherapy (Avastin is not a chemo drug) in terms of providing for quality of life. In some cases, as noted in the article, it is the only thing that works. Cancer treatment is still a highly individualized process.

    Avastin is indeed a very expensive treatment. The FDA says that is not a consideration, but it is always the 600 pound gorilla in the room with this drug. Sarah Palin and her accusation of death panels doesn't seem nearly as daffy today – only we're not calling them death panels, we're calling them Outcome Based Treatments.

    June 29, 2011 at 23:12 | Report abuse | Reply
    • Jon

      ... what makes you think the insurance companies would have paid for it anyway?

      July 1, 2011 at 00:21 | Report abuse |
  7. Andre

    CBD (cannabidiol) is the most promising compound for treating breast cancer.. and several other types.

    June 30, 2011 at 04:29 | Report abuse | Reply
  8. Kevin

    ...and now they are censoring posts about corruption at the FDA. (why am I not all that suprised?)

    June 30, 2011 at 05:57 | Report abuse | Reply
    • Elizabeth

      A number of years ago, TAP Pharmaceuticals was fined a huge amount for bribing doctors to give some hormone therapies for both prostate cancers and endometriosis. (Generic called GNRH agonists, brand name Lupron). Look it up: the board who had approved Lupron were almost all from TAP; the FDA just used the same industry to approve the drug. Side effects and dangerous effects were never pursued. Changes in the brain were noted by users, but not by either the FDA nor TAP. This drug is still being used, but is completely ineffective for prostate cancer or endometriosis, and can cause blurred vision, memory problems, major depression, spelling problems, reading problems... the long-term effects of this drug on the brain have never been evaluated. (Prostate cancer is better treated with radiation or seed therapy. Other hormones or surgery are better for endometriosis.) The FDA either listens to big pharma or big insurance when it makes its decisions.

      July 1, 2011 at 00:49 | Report abuse |
  9. Lagos

    Awesome. My friend/former landlady has inoperable breast cancer, just finished her fifth month on Avastin and not only has it helped with regression, it got her to the point where surgery is possible.

    So, 100% elective treatments like Botox are perfectly fine and safe, but our government overlords clearly know better than our doctors about what can help who. I understand that this is the FDA we're talking about, but the fact of the matter is that this decision will cost lives. If you want to highly restrict the drug, awesome. It's not perfect, it has side effects. But let doctors make the call. And you wonder why people are paranoid about government-run healthcare?

    June 30, 2011 at 09:11 | Report abuse | Reply
    • A scientist

      Something that this article does not make clear is that because Avastin is approved for other uses, doctors will still be allowed to prescribe it in spite of the FDA's decision. The major effect of this ruling is likely to be that some insurance companies may not cover its cost. In other words, patients can still take the drug if they choose, they just might need to pay for it themselves.

      To me, this seems like a reasonable compromise. When an insurance company (or Medicare/Medicaid) pays for a treatment, we all bare the costs through higher insurance premiums or taxes. This is reasonable when a drug has been shown to be effective - after all, we pay for insurance so that it will cover our medical costs. However, when a drug has not been shown to have any net benefit, it is unreasonable to expect everyone else to pay for it. People are welcome to try treatments that have not been shown to be effective (whether it be bad drugs, untested herbal remedies or faith healing), but they shouldn't expect other people to pay for them.

      June 30, 2011 at 13:50 | Report abuse |
    • Elizabeth

      Scientist: It is not reasonable to tell people that because they are rich they can take a drug, but if they are not rich, they can't. So the rich will continue to take Avastin for whatever they want to. Is this Palin care?

      July 1, 2011 at 00:52 | Report abuse |
  10. cag31

    To Lagos – I said I think more tests and trials need to be done, because, my husband who had lung cancer was taking Avastin along with chemo. He developed blood clots in his legs and stomach (a side effect of Avastin and maybe only in lung cancer patients). A blood clot hit his lung and he passed away within 3 months of taking the drug. I am in group therapy for those who have lost someone to cancer and another person lost their spouse to lung cancer in the same way. I am saying it has worked well for some breast cancer patients and I am glad for that. I am not so sure about lung cancer patients. It may not be the answer for that type of cancer

    June 30, 2011 at 10:31 | Report abuse | Reply
  11. watergirl

    Figure it out...if there was a drug that could cure cancer, there would be a HUGE drop in health care expenses and Rx expenses. The big drug companies and health care industry DO NOT want this! Curing cancer of any kind would seriously dent their financial bottom line. They prefer to continue to make money...even if people have to die horrible deaths...they want their $$$$$

    June 30, 2011 at 11:29 | Report abuse | Reply
    • Jon

      I don't think anyone – even the company that makes it – claimed that Avastin was a cure.

      July 1, 2011 at 00:19 | Report abuse |
    • jjj4567

      It is not a cure, and compared with other ways available to treat breast cancer not a good choice. Determining what helps fight cancer is not based on what someone believes cured their cancer. Go on line you will find a lot of testimonials from patients who say they were cured of cancer by diets, drugs, and healers. These patients usually "know" what cured them. In order to determine if a substance or activity helps fight cancer a large study needs to be done. In the case of Avastin the large study showed that more people where hurt by taking the drug, and help was modest. This was not the result the drug company wanted and they argued that there drug should still be used. The FDA went with the data and not the possibility that at sometime someone might find a way to pick out breast cancer patients who will be helped by the drug. Avastin is still approved for use to treat other cancers.

      July 1, 2011 at 08:39 | Report abuse |
  12. For the Poor People

    There are far cheaper natural VEGF-A inhibitors (that's what Avastin does) that won't run you even close to $88,000 a year. Avastin is not a scam??

    June 30, 2011 at 12:01 | Report abuse | Reply
  13. Eliza57

    A question for you all:
    What have been the success/failure breast cancer results out of Europe? Canada? Where the FDA does not regulate Avastin?
    And I must admit when the FDA does ban a drug so vehemently (6-0) it makes me wonder if the health industry is not beginning to do calculations as to what their bottom line will lose. "Cancer" has become quite an industry in and of itself and having had "it" myself and lost family members and friends to "it" I have seen over the decades the differing forms of treatments prescribed. The costs are astronomical in this country and with a stroke of a pen the FDA does have the power to make them unreachable. Extremely frustrating. And it is an emotional issue when one is dealing with such life & death decisions. Doctors & healers practice medicine – let's hope & pray they get it right with this one.

    June 30, 2011 at 16:14 | Report abuse | Reply
  14. rhythmdoc

    Cancer therapy is extremely emotional and, unfortunately, often significantly toxic. In such settings, we simply MUST make our decisions on facts, data, and analysis...if we abandon our best scientific thinking at these times, we are rudderless. If our best science tells us that the risk is not outweighed by the benefit, then how can we in good faith use a potentially toxic agent to provide hope instead of benefit?

    And while it cannot matter for this decision, it is interesting that this same drug appears to have significant benefit for macular degeneration, and absolutely fascinating that Genentech created a version specifically labelled for this indication, and increased the price by as much as 40-fold! (Check out this month's Scientific American article on "The Best Medicine"

    June 30, 2011 at 18:45 | Report abuse | Reply
  15. Jon

    Well. I'm glad they reconsidered, at least. And it sounds like they at least let other points of view into the discussion.

    July 1, 2011 at 00:18 | Report abuse | Reply
  16. Jon

    Also, can I say that I appreciate the doctors and actual scientists who are contributing to the discussion here? Thank you all. You make hanging out around here somewhat worth it.

    July 1, 2011 at 00:20 | Report abuse | Reply
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