[Skip to Navigation]
Views 1,831
Citations 0
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

Limit 200 characters
Limit 25 characters
Conflicts of Interest Disclosure

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.

Limit 140 characters
Limit 3600 characters or approximately 600 words
    ×