Economics of new oncology drug development.
Abstract
PURPOSE: Review existing studies and provide new results on the development, regulatory,
and market aspects of new oncology drug development. METHODS: We utilized data from
the US Food and Drug Administration (FDA), company surveys, and publicly available
commercial business intelligence databases on new oncology drugs approved in the United
States and on investigational oncology drugs to estimate average development and regulatory
approval times, clinical approval success rates, first-in-class status, and global
market diffusion. RESULTS: We found that approved new oncology drugs to have a disproportionately
high share of FDA priority review ratings, of orphan drug designations at approval,
and of drugs that were granted inclusion in at least one of the FDA's expedited access
programs. US regulatory approval times were shorter, on average, for oncology drugs
(0.5 years), but US clinical development times were longer on average (1.5 years).
Clinical approval success rates were similar for oncology and other drugs, but proportionately
more of the oncology failures reached expensive late-stage clinical testing before
being abandoned. In relation to other drugs, new oncology drug approvals were more
often first-in-class and diffused more widely across important international markets.
CONCLUSION: The market success of oncology drugs has induced a substantial amount
of investment in oncology drug development in the last decade or so. However, given
the great need for further progress, the extent to which efforts to develop new oncology
drugs will grow depends on future public-sector investment in basic research, developments
in translational medicine, and regulatory reforms that advance drug-development science.
Type
Journal articleSubject
Antineoplastic AgentsDrug Approval
Drug Costs
Drug Design
Drug Industry
Economics, Pharmaceutical
Humans
Neoplasms
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https://hdl.handle.net/10161/6612Published Version (Please cite this version)
10.1200/JCO.2006.09.0803Publication Info
DiMasi, Joseph A; & Grabowski, Henry G (2007). Economics of new oncology drug development. J Clin Oncol, 25(2). pp. 209-216. 10.1200/JCO.2006.09.0803. Retrieved from https://hdl.handle.net/10161/6612.This is constructed from limited available data and may be imprecise. To cite this
article, please review & use the official citation provided by the journal.
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Show full item recordScholars@Duke
Henry G. Grabowski
Professor Emeritus of Economics
Professor Grabowski specializes in the investigation of economics in the pharmaceutical
industry, government regulation of business, and the economics of innovation. His
specific interests within these fields include intellectual property and generic competition
issues, the effects of government policy actions, and the costs and returns to pharmaceutical
R&D. He has been publishing research papers for over four decades, from his earlier
work, “The Effects of Regulatory Policy on the Incentives

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