A Washington Post story about the U.S. Food and Drug Administration’s review of its advisory’s panel’s recommendation to revoke approval of Avastin (bevacizumab) for the treatment of advanced breast cancer has resulted in a whole lot of blog postings and readers’ comments about death panels and the evils of “Obamacare.”  So, I think it’s important to take the time to look closely at what this decision is really all about.

Last month, the FDA Oncologic Drugs Advisory Committee voted 12-1 to recommend that the agency revoke approval of Avastin.  This decision was the result of findings from two new studies which showed that the level of improvement in women who received chemotherapy and Avastin was not significantly better than that of women who received chemotherapy alone. The new studies also showed that the women who took Avastin experienced more serious side effects, including bleeding, blood clots and gastrointestinal perforations.

Avastin received “accelerated approval” in 2008 for the treatment of patients who have not yet received chemotherapy for metastatic HER2-negative breast cancer. The FDA can grant accelerated approval for therapies for cancer and other life-threatening diseases when initial clinical data is positive. In this case, the preliminary date came from a Phase III study that showed that the combination of Avastin and paclitaxel extended progression-free survival by 5.5 months when compared with paclitaxel alone. (This accelerated approval was also controversial, as drug makers are usually required to show that a cancer drug extends overall survival, which the study did not show.)

Since then, about 17,500 women a year have been prescribed Avastin, which costs about $8,000 a month. But while these women were taking Avastin, clinical trials continued. That’s because after a drug has received accelerated approval its manufacturer must submit more data from studies that have followed patients longer to receive full approval. The new studies showed that the drug only extended progression-free survival by, at most, 2.9 months and had no effect on overall survival. And remember, extending survival does not mean that you are symptom-free. It means that you might live 2-3 months longer than the women not taking it.

Not surprisingly, the drug’s manufacturers are arguing that the FDA should not revoke the drug’s approval and that it should remain an option for women with advanced breast cancer. But all I can say to that is: Why? Have we learned nothing from the debacle of high dose chemotherapy and stem cell rescue? Women sued their insurance companies to get this treatment after being sold magic by doctors and hospitals and when the dust settled and the studies were done it was found to be no better than standard chemotherapy—and with many more significant and sometimes fatal side effects!

The FDA advisory’s panel’s recommendations do not stem from some evil desire to keep women from getting effective treatments, or from an insurance company’s desire to keep expensive drugs out of patient’s hands. They are based on what the data show. We conduct clinical trials to get this data, and it makes no sense to do studies if we don’t pay attention to the findings. Revoking approval for Avastin for breast cancer is not going to cause more women to die or to die more quickly because there is no difference between taking paclitaxel and Avastin than taking paclitaxel alone.  Furthermore, treatment with only paclitaxel results in fewer serious side effects.

I wish that wasn’t the case. But it is—and wishing won’t change the situation. We need treatments that work not drugs that we wished worked!

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11 Responses to Avastin: A Wish Falls Short

  1. Jen says:

    Thanks for the updated news. I am going this week to my oncologist to decide about an aromatase inhibitor. Certainly won’t be avastin.

  2. LIoness says:

    Dr. Love, in the rather stodgy, conservative world of pink hypocresy that is breast cancer politics and the millions of women who unquestioningly follow them you are a breath of fresh air. Kudos to your stance on the new mammogram guidelines, your interest in what the science says about Avastin and your open-ness about the perils of chemotherapy. There will not be a cure for breat cancer without more people like you who have the brains to swim against the tide of hysteria. As a breast cancer patient, I cannot tell you how dismayed I have been with the retrograde views and groupie cliqu-ism that exists about breast cancer treatment amongst so many women. Fear, not cancer, is our biggest enemy.

  3. kathleen schultz says:

    This is helping me to decide whether or not to participate in a clinical trial regarding this drug. I currently do not have metastic breast cancer but they are offering this trial to see how women respond who don’t have metastic cancer with this added drug. I feel the potential side effects, though they may be rare, are horrific. I feel pressure to be in this study. I think I am going to say no. Wish there was a better clinical trial out there. Not against the trials, just this one.

  4. Libby Ortiz says:

    Thanks for this update. i was offered Avastin to take along with Navalbine, but declined because of all side effects, my MD said also stroke.
    As a 4 years metastasized to the bone, symptom free patient I have found that the tx’s are so toxic and cumulative that I am about to stop with chemo altogether and take my chances – have fun in the short run.

  5. Anne Vincent says:

    Perhaps inhibition of vascular supply to metastatic tumors (in advanced breast cancer) does not provide enough regression of metastatic disease, to translate into better survival. But this does not necessarily mean that inhibition of vascular supply to earlier stages of very aggressive disease will not result in great benefits, in terms of inhibition of metastatic spread of this more aggressive tumor type. This could, potentially, provide some significant advantage for those with very aggressive tumor types that are not going to be suppressed by even dose-dense chemotherapy and hormone therapy, alone. Just a thought.

  6. Sandrala says:

    But what about us patients for whom Avastin may have been beneficial? Taxol with Avastin has reversed the disease for me. We cannot know what it would have been like with Taxol alone.

    Beyone progression free survival and overall survival rates, what we really need is a cure. Please!

  7. Jana says:

    Bravo to Dr. Love for being brave enough to say what needed to be said about Avastin. Thanks.

  8. Dianne says:

    I have been taking Avastin now for 6 monthis. Avastin has been benificial for me. I will discuss continuing with my MD. Are there any data to show how many ladies have benifitied from the drug?

  9. Christi says:

    27 months PFS Fatigue and body aches are my only side effects. NED after 4 treatments. Still NED. On avastin alone x 18 mos. TNBC Just one of many with similar stats. It works well for some of us. Need more studies to determine who are the best candidates!!

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  11. Hi, Dr. Love,

    Thanks for this informative and clear explanation of the situation. I’m writing about this issue for LBBC.

    What do you think about other oncologists who suggest bevacizumab may be extremely effective in particular subtypes of cancer but not in all types, and that we have not yet discovered which cancers are most likely to respond to it? Should clinical trials of this drug continue, or do you think evidence is strong enough to pull all breast cancer indications?

    I see here that your members disagree, and we see the same thing at LBBC. We definitely have women who have taken this drug and done very well, whereas others have major concerns.

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