title: Evaluation of oncology drugs at the European Medicines Agency and US Food and Drug Administration: when differences have an impact on clinical practice.
abstract: OBJECTIVE
  The aims of this study were to compare the approaches of the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) in the evaluation and approval of new anticancer indications and to identify possible clinical implications associated with these differences.
  
  
  METHODS
  Information on the European Union therapeutic indications for the cohort of anticancer drugs was extracted from the European Public Assessment Reports and from the FDA review reports.
  
  
  RESULTS
  Overall, 42 anticancer drugs were approved by EMA between 1995 and 2008, corresponding to a total of 100 indications. In 47 of 100 indications, a difference was found. For 19 of these 47 indications, the difference was that one agency approved an indication, whereas the other agency did not. For the remaining 28 indications, the same indication was approved by both of the agencies and differences were evaluated through an algorithm; in 10 cases, discrepancies in therapeutic indications between EMA and FDA were considered clinically relevant. We found an overall trend that the agency that was second to give a positive approval was usually more restrictive in terms of wording of the indication compared with the agency that provided approval first. Regarding the use and robustness of available clinical data for evaluation, no clear associations could be found.
  
  
  CONCLUSIONS
  Clinically relevant differences in the outcome of the EMA and FDA approval process of oncology products were found. Neither of the agencies seems to have a prevailing restrictive behavior over the other. Further efforts on harmonizing decision making between regulatory systems are needed.
authors.affiliation: Italian Medicines Agency, Rome, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Trotta
authors.forename: Hubert G M
authors.initials: HG
authors.lastname: Leufkens
authors.forename: Jan H M
authors.initials: JH
authors.lastname: Schellens
authors.forename: Richard
authors.initials: R
authors.lastname: Laing
authors.forename: Giovanni
authors.initials: G
authors.lastname: Tafuri
mesh_terms: D000970:Antineoplastic Agents; D017277:Drug Approval / Q000331:legislation & jurisprudence / Q000458:organization & administration; D005060:Europe; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000970:Antineoplastic Agents