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 |