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Office of Oncology Drug Products approved 53 of 60 applications in 2.5 years
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From July 1, 2005, to Dec. 31, 2007, the Office of Oncology Drug Products in the Center for Drug Evaluation and Research at the FDA reviewed 60 new oncology drug and biological licensing applications and supplementary applications. They took regulatory action on 58 applications and approved 53.
Eighteen of the products approved for new indications were new molecular entities and 35 were existing products approved for supplemental indications. Thirty-nine applications received regular approval based on evidence of clinical benefit, nine received accelerated approval and five were changed from accelerated to regular approval.
Thirty-nine of the applications were priority reviews, a six-month review cycle; 14 were standard reviews, a 10-month review cycle. Overall, 44 were approved based on findings from a single study.
Among the approvals that received regular approval, 10 used OS, four used DFS, three used OS and PFS, 11 used PFS or time to progression, 10 used objective response rate and six used other novel endpoints. For indications given accelerated approval, one used time to progression, six used objective response rate and one was based on other novel endpoints.
Thirty-seven approvals were based on findings from randomized studies, while 16 were based on findings from single-arm studies. Five products were not approved during the study period.
For more information:
- Sridhara R. J Natl Cancer Inst. 2010;102:doi:10.1093/jnci/djp515.