FDA: Avastin Not Shown to be Safe and Effective in Breast Cancer Patients

November 18, 2011 Updated Nov 18, 2011 at 12:57 PM EDT

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FDA: Avastin Not Shown to be Safe and Effective in Breast Cancer Patients

November 18, 2011 Updated Nov 18, 2011 at 12:57 PM EDT

According to a news release issued Friday, U.S. Food and Drug Administration commissioner Margaret A. Hamburg announced she is revoking the agency's approval of of the breast cancer indication for Avastin after concluding that the drug has not been shown to be safe and effective for that use.

Avastin will still remain on the market as an approved treatment for certain types of colon, lung, kidney and brain 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,” Hamburg said in the news release. “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.”

Read the entire FDA release HERE.