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Invited Commentary
February 22, 2021

Approval and Coverage of Cancer Drugs in England, Canada, and the US

Author Affiliations
  • 1Department of Medicine, University of California, San Francisco
  • 2Department of Epidemiology and Biostatistics, University of California, San Francisco
  • 3Division of Hematology and Medical Oncology, Knight Cancer Institute, Oregon Health and Science University, Portland
JAMA Intern Med. 2021;181(4):509-510. doi:10.1001/jamainternmed.2020.8587

For approval of cancer drugs, the US Food and Drug Administration (FDA) is tolerant of uncertainty and prioritizes speed over other factors.1 Most drug approvals are based on surrogate markers, such as tumor shrinkage in a fraction of patients (response rate) or delayed tumor growth (progression-free survival). These surrogates use arbitrary percentage cutoffs and are not optimized to ensure that a drug can improve the length or quality of life.2

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