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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Prasad V, Kim MS. Approval and Coverage of Cancer Drugs in England, Canada, and the US. JAMA Intern Med. 2021;181(4):509–510. doi:10.1001/jamainternmed.2020.8587
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