FDA Withdraws Approval of Avastin for Breast Cancer
On Friday, FDA announced that is revoking the accelerated approval of Genentech's Avastin for the treatment of metastatic breast cancer. In a 69-page decision, FDA Commissioner Margaret Hamburg said clinical trials showed that the drug was ineffective in extending patients' lives and exposed patients to several harmful side effects. Avastin will remain on the market for the treatment of certain types of colon, lung and kidney cancer,Â so physicians could prescribe it off-label for breast cancer. However, some insurers might stop covering the medication, which costs about $88,000 annually. Federal officials said Medicare will continue to cover use of the drug to treat breast cancer but plans to "monitor the issue and evaluate coverage options."
- "FDA Revokes Approval of Avastin for Use as Breast Cancer Drug" (Pollack, New York Times, 11/18).
- "FDA Revokes Avastin's Approval for Breast Cancer Treatment" (Stein, Washington Post, 11/18).