FDA Announces Final Decision to Revoke Avastin Breast Cancer Decision

As expected, the U.S. Food & Drug Administration (FDA) had revoked its approval of Avastin as a treatment for breast cancer. In doing so, the FDA concluded that Avastin was not a safe or effective treatment for breast cancer.

“This was a difficult decision. 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,” Dr. Margaret Hamburg, FDA commissioner, said in a statement. “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.”

Avastin will remain on the market as a treatment for certain types of colon, lung, kidney and brain cancer (glioblastoma multiforme). Doctors could continue to use Avastin off-label for breast cancer, but insurance companies will likely stop paying for Avastin for this use. Treatment with Avastin costs in the neighborhood of $88,000 a year.

The FDA announced in December that it was beginning the process of revoking Avastin’s breast cancer approval. Serious complications from Avastin include bleeding and hemorrhage; the development of perforations in the intestines and other areas of the body; and heart attack or heart failure. The FDA said its review of the drug did not show that Avastin slowed tumor growth or prolonged survival time in women with metastatic breast cancer.

Avastin was approved for metastatic breast cancer in February 2008 under the FDA’s accelerated approval program. But two studies conducted by the drug’s maker, Genentech, later showed only a small effect on tumor growth without evidence that patients lived any longer or had a better quality of life compared to taking standard chemotherapy alone – not enough to outweigh the risk of taking the drug, the FDA said.

According to a report from The New York Times, Genentech said in a statement that it was “disappointed with this outcome.” It said it would continue with plans to conduct another clinical trial in an effort to regain approval.

While some insurers had stopped paying for Avastin back in December, others had put the decision on hold until the FDA made its final ruling. Medicare, however, which covers many women with breast cancer, has already said it would continue to cover the cost regardless of the FDA’s action. Medicare is obligated to pay for off-label use of cancer drugs that are listed in references known as compendia, such as the one published by the National Comprehensive Cancer Network, the Times said. Over the summer, that organization reaffirmed that Avastin should remain listed as “an appropriate therapeutic option for metastatic breast cancer.” Other health insurers that are guided by that compendium, such as UnitedHealthCare, will therefore likely continue paying for the treatment.

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