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
Identify all potential conflicts of interest that might be relevant to your comment.
Conflicts of interest comprise financial interests, activities, and relationships within the past 3 years including but not limited to employment, affiliation, grants or funding, consultancies, honoraria or payment, speaker's bureaus, stock ownership or options, expert testimony, royalties, donation of medical equipment, or patents planned, pending, or issued.
Err on the side of full disclosure.
If you have no conflicts of interest, check "No potential conflicts of interest" in the box below. The information will be posted with your response.
Not all submitted comments are published. Please see our commenting policy for details.
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
Coronavirus Resource Center
Customize your JAMA Network experience by selecting one or more topics from the list below.