Cancer drugs approved on the basis of a surrogate end point and subsequent overall survival: An analysis of 5 years of us food and drug administration approvals

JAMA Internal Medicine

Volumn 175, Issue 12, 2015, Pages 1992-1994

  Kim, Chul ^a   Prasad, Vinay ^b  

^a NATIONAL CANCER INSTITUTE   (United States)

^b OREGON HEALTH AND SCIENCE UNIVERSITY   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ANTINEOPLASTIC AGENT;

DISEASE FREE SURVIVAL; DRUG APPROVAL; DRUG EFFICACY; FOLLOW UP; FOOD AND DRUG ADMINISTRATION; HUMAN; LETTER; OVERALL SURVIVAL; PRIORITY JOURNAL; PROGRESSION FREE SURVIVAL; UNITED STATES; BIOASSAY; PROCEDURES;

ANTINEOPLASTIC AGENTS; DRUG APPROVAL; ENDPOINT DETERMINATION; FOLLOW-UP STUDIES; HUMANS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84964837459     PISSN: 21686106     EISSN: None     Source Type: Journal    
DOI: 10.1001/jamainternmed.2015.5868     Document Type: Letter

References (4)

1. Fauber J. FDA approves cancer drugs without proof they're extending lives. Milwaukee Sentinel. October 26, 2014. http://www.jsonline.com/watchdog/watchdogreports/fda-approves-cancer-drugs-without-proof-theyre-extending-lives-b99348000z1-280437692.html. Accessed August 24, 2015.
2. Prasad V, Kim C, Burotto M, Vandross A. The strength of association between surrogate end points and survival in oncology: a systematic review of trial-level meta-analyses. JAMA Intern Med. 2015;175(8):1389-1398.
3. US Government Accountability Office. FDA needs to enhance its oversight of drugs approved on the basis of surrogate endpoints. GAO-09-866. http://www.gao.gov/products/GAO-09-866. Published September 23, 2009. Accessed August 24, 2015.
4. Herper M. The FDA is basically approving everything: here's the data to prove it. Forbes. http://www.forbes.com/sites/matthewherper/2015/08/20/the-fda-is-basically-approving-everything-heres-the-data-to-prove-it/. Posted August 20, 2015. Accessed August 24, 2015.