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Table 1 History of regulatory events

From: Regulatory withdrawal of medicines marketed with uncertain benefits: the bevacizumab case study

Date FDA decisions
26 February 2004 FDA approval of bevacizumab as first-line treatment for metastatic colorectal cancer in combination with intravenous 5-fluorouracil
20 June 2006 FDA approval of bevacizumab as second-line treatment for metastatic colorectal cancer
5 December 2007 ODAC voted 5 to 4 against the recommendation bevacizumab for treatment of metastatic breast cancer in combination with paclitaxel
22 February 2008 FDA granted accelerated approval of bevacizumab in combination with paclitaxel for the treatment of metastatic breast cancer
20 July 2010 ODAC voted 12 to 1 revoking approval of bevacizumab for the treatment of metastatic HER2 negative breast cancer
16 December 2010 FDA initiated the withdrawal process
16 January 2011 Genentech requested an hearing
28–29 June 2011 FDA Oncologic Drugs Advisory Committee hearing recommended the indication withdrawal
18 November 2011 FDA withdrew officially the indication