us fda approval process of oncology drugs

Inpharma 1387 - 17 May 2003 ■ The endpoints used by the US FDA to approve new oncology drug applications have been summarised, and the rationale for each endpoint has been discussed, by Dr John Johnson and colleagues from the Center for Drug Evaluation and Research, Rockville, Maryland, US. They say that between 1 January 1990 and 1 November 2002, the FDA granted marketing approval to 71 oncology drug applications; 57 were granted regular approval and 14 were granted accelerated approval. Thirty-nine of 57 (68%) of the regular approvals and all of the 14 accelerated approvals were based on endpoints other than survival. Excluding chemoprotectant and bisphosphonate applications, 34 of 52 regular approvals were based on nonsurvival endpoints. Tumour response was the approval basis in 26 of the regular approvals, and in 12 of the accelerated approvals. Johnson JR, et al. End points and United States Food and Drug Administration approval of oncology drugs. Journal of Clinical Oncology 21: 1404-1411, 1 Apr 2003 800925873 1 Inpharma 17 May 2003 No. 1387 1173-8324/10/1387-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

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Page 1: US FDA approval process of oncology drugs

Inpharma 1387 - 17 May 2003

■ The endpoints used by the US FDA to approvenew oncology drug applications have beensummarised, and the rationale for each endpoint hasbeen discussed, by Dr John Johnson and colleaguesfrom the Center for Drug Evaluation and Research,Rockville, Maryland, US. They say that between 1January 1990 and 1 November 2002, the FDA grantedmarketing approval to 71 oncology drug applications;57 were granted regular approval and 14 were grantedaccelerated approval. Thirty-nine of 57 (68%) of theregular approvals and all of the 14 acceleratedapprovals were based on endpoints other thansurvival. Excluding chemoprotectant andbisphosphonate applications, 34 of 52 regularapprovals were based on nonsurvival endpoints.Tumour response was the approval basis in 26 of theregular approvals, and in 12 of the acceleratedapprovals.Johnson JR, et al. End points and United States Food and Drug Administrationapproval of oncology drugs. Journal of Clinical Oncology 21: 1404-1411, 1Apr 2003 800925873

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