Avastin loses FDA approval for breast cancer


Former Executive Editor, Harvard Health

The FDA today revoked its 2008 approval of the drug Avastin to treat breast cancer, concluding that the drug does little to help women with breast cancer while putting them at risk for potentially life-threatening side effects. Avastin will remain on the market (and so be potentially available to women with breast cancer) because it has also been approved to treat other types of cancer.

In a statement, FDA Commissioner Margaret A. Hamburg said this:

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. After reviewing the available studies it is clear that women who take Avastin for metastatic breast cancer risk potentially life-threatening side effects without proof that the use of Avastin will provide a benefit, in terms of delay in tumor growth, that would justify those risks. Nor is there evidence that use of Avastin will either help them live longer or improve their quality of life.

Why does this happen?

Every new drug is tested in a series of clinical trials. Small phase I trials evaluate a drug’s safety, determine a safe dosage range, and identify side effects. Somewhat larger phase II trials test the drug’s effectiveness and further check its safety. In phase III trials, the drug is given to large, carefully defined groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and gather other information on side effects and safety. Phase III trials are the ones the FDA uses to determine if a new drug should be approved.

Avastin went through this process. In the two phase III trials on which the FDA based its approval, the drug was tested in just under 1,200 women. As a condition of approval, the FDA required Genentech, the company that made the drug, to carry out additional trials. These weren’t so positive.

Another important issue is that real life is messier and more diverse than clinical trials. Once a drug is approved, anyone with the specified condition can take it. The folks taking the drug may be older than those allowed into the phase III clinical trials, have other medicals conditions, be taking other medications, or have other important differences from the clinical trial populations. And that often translates into less effectiveness and more side effects and complications than seen in the trials. Although the FDA often requires companies to study how the drug performs once it is being used in clinical practice, a report by the Department of Health and Human Service’s Office of Inspector General found that the FDA often doesn’t follow up to make sure these studies are undertaken.

We’re all individuals

The FDA bases its decisions on data collected from large, diverse groups. While the decision that Avastin isn’t effective against breast cancer applies to most women, it is possible that some women may benefit from the drug. But at least for now, it’s impossible to know in advance who might benefit from the drug.

The Avastin story underscores the idea that it takes a while for a drug’s full effects to be revealed. In other words, when it comes medications, new isn’t necessarily better.

Related Information: Living Through Breast Cancer


  1. Heather Smith

    This is a good article,the idea is that it takes a while for a drug full effects to be revealed. I am thankful for the FDA effort in testing this new drugs.

  2. patti willson

    I have been touched my loved ones who have suffered through breast cancer. I know steps are taken to ensure the drugs approved to treat breast cancer are effective, but it does become a bit scarier when approved drugs are pulled. But I understand when new information becomes available it is prudent to take those steps.(www.cprescue.com)

  3. Adan Harris

    In wake of these updates for Breast cancer, I am a little scared that drugs that pose to be life for someones existence are rendered dangerous after sometime. How is it possible that Avastin got a go earlier and now its dangerous. Further more, cancer has also been linked to obesity, losing weight is great option for it. All these things baffle me sometimes. But it is advisable to follow updates like so one can dig a deeper into things.

  4. Stan Smith

    Great post very informative and easy to read. I have added this blog to my bookmarks.

  5. Casey Lopez

    It’s scary to think that there are drugs that is meant to heal but in reality it will give more problems.

    I believe there should be more thorough studies regarding drugs in cure for cancer

  6. Tytti Laiho

    Does this affect the use of Avastin-injections for exudative macular degeneration?

  7. Joshua Session

    Drugs like this that are life threatening are funded and studied while marijuana remains a class I drug by the DEA. There is a lot of evidence that marijuana made be the real cure for cancer. Harvard, what is the hold up?

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