The FOIA request also seeks documents regarding the processes by which the FDA reached its conclusions regarding Avastin, the communications between the FDA and various outside parties, any discussions related to the costs of Avastin in the FDA review process, conflicts of interest by those party to the Avastin decision, and other relevant issues.

The filers also seek the scientific basis for the FDA's decision with document requests related to risk and benefit evaluation of Avastin, comparison of the risk / benefit of Avastin versus current approved drugs, the use of progression free survival as a primary end point in cancer drug evaluation and the FDA's criteria for evaluation of toxicity under its Accelerated Approval Process.

The European Medicines Agency's advisory board recommended on April 15th, 2011 expanded use for Avastin for mbc. This follows the National Comprehensive Cancer Network's (an organization of leading U.S. cancer centers treating 160,000 patients per year) second vote to confirm retaining Avastin for use with mbc. The FOIA request includes documents related to how the FDA's decision-making process reached the opposite conclusion on Avastin from these bodies.    

SOURCE Freedom of Access to Medicines