چکیده (انگلیسی):

On November 18, 2011, the US Food and Drug Administration (US FDA) announced
that breast cancer indication for Avastin (bevacizumab) had been withdrawn after concluding that
the drug has not been shown to be safe and effective for the treatment of breast cancer. The specific
indication that was withdrawn was for the use of bevacizumab in metastatic breast cancer, with
paclitaxel for the treatment of patients who have not received chemotherapy for metastatic
HER2-negative breast cancer.
The US FDAs decision has been met with emotion and confusion among the public and health
professionals. The purpose of this article is to review the regulatory history of bevacizumab for
breast cancer and to examine the scientific evidence that led to the approval and subsequent withdrawal
of this indication. Bevacizumab also provides the opportunity to illustrate the value of free
publicly available US FDA reviews that may contain rigorously reviewed unpublished data and
analyses and to contrast the decisions made in the US and Europe about bevacizumab and breast
cancer.