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Research Letter
Health Care Policy and Law
February 2017

Quality of Life, Overall Survival, and Costs of Cancer Drugs Approved Based on Surrogate Endpoints

Author Affiliations
  • 1National Center for Health Research, Washington, DC
JAMA Intern Med. 2017;177(2):276-277. doi:10.1001/jamainternmed.2016.7761

The lack of evidence of a clinically meaningful benefit for many cancer drugs approved by the US Food and Drug Administration (FDA) through expedited pathways raises questions about whether physicians and patients can make informed treatment decisions.1 Kim and Prasad2 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, tumor shrinkage or progression-free survival—postmarket studies did not indicate any overall survival (OS) benefit. To determine other potential benefits of these 18 drugs, we analyzed all peer-reviewed findings and FDA review summaries for quality of life (QoL) and calculated the drugs’ annual cost to assess their value.

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