title: Economics of new oncology drug development.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Tufts Center for the Study of Drug Development, Tufts University, Boston, MA 02111, USA. joseph.dimasi@tufts.edu
authors.forename: Joseph A
authors.initials: JA
authors.lastname: DiMasi
authors.forename: Henry G
authors.initials: HG
authors.lastname: Grabowski
mesh_terms: D000970:Antineoplastic Agents / Q000191:economics* / Q000627:therapeutic use; D017277:Drug Approval / Q000191:economics; D016527:Drug Costs; D015195:Drug Design; D004345:Drug Industry / Q000191:economics*; D017850:Economics, Pharmaceutical; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy / Q000191:economics
chemical_list: D000970:Antineoplastic Agents