Posted by Michael Wonder on 29 Nov 2016
Quality of life, overall survival, and costs of cancer drugs approved based on surrogate endpoints
29 November 2016 - The lack of evidence of a clinically meaningful benefit for many cancer drugs approved by the US FDA through expedited pathways raises questions about whether physicians and patients can make informed treatment decisions.
Kim and Prasad reported that for 18 of the 36 cancer drugs that were approved by the FDA from 2008 to 2012 on the basis of a surrogate endpoint—typically, tumour shrinkage or progression-free survival—post-market studies did not indicate any overall survival benefit.
To determine other potential benefits of these 18 drugs, we analyzed all peer-reviewed findings and FDA review summaries for quality of life and calculated the drugs’ annual cost to assess their value.
