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Avastin's approval as a breast cancer treatment is being revoked by the FDA

December 16, 2010|By Mary Forgione, Los Angeles Times
(Roche Holding AG via Bloomberg…)

Avastin hasn't proved to be a safe and effective treatment for breast cancer patients, and the U.S. Food and Drug Administration has taken steps to withdraw approval of Avastin for such treatment, an FDA statement released Thursday says.

The FDA action on Avastin, known generically as bevacizumab, isn't all that surprising. This Los Angeles Times article reports that an advisory panel in July recommended withdrawing approval for breast cancer treatment.

The FDA statement says in part: "The agency is making this recommendation after reviewing the results of four clinical studies of Avastin in women with breast cancer and determining that the data indicate that the drug does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh the significant risk to patients.

"These risks include severe high blood pressure; bleeding and hemorrhage; the development of perforations [or "holes"] in the body, including in the nose, stomach, and intestines; and heart attack or heart failure."

But taking this action won't happen overnight. Read the full FDA announcement here to learn what steps the agency will take next. In the meantime, Avastin remains an approved drug treatment for kidney, brain and lung cancers.

Here's what HealthKey.com has to say about Avastin. And this National Cancer Institute report provides a list of all treatment options for breast cancer. 

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