ARTICLE | Regulation
Arguing for Avastin
Why Genentech says FDA moved the goalposts for Avastin in breast cancer
January 24, 2011 8:00 AM UTC
Information made public last week by Genentech Inc. suggests FDA moved the goalposts between granting accelerated approval to Avastin bevacizumab to treat metastatic breast cancer in 2008 and proposing to withdraw the indication last month.
In a written response to a notice of opportunity for a hearing, Genentech said that prior to approving the sBLA, FDA had already considered data the agency is now citing as justification for withdrawal...