title: The changing world of cancer drug development: the regulatory bodies' perspective.
abstract: BACKGROUND
  Although not a singular disease entity, advanced cancer continues to be a largely intractable disease and a high unmet medical need situation. Discovery of novel therapeutic modalities, including new drugs targeting cancer, is undoubtedly of major public health interest.
  
  
  METHODS
  In this article, we discuss current trends in oncology drug development as these are ultimately reflected in regulatory drug approvals.
  
  
  CONCLUSIONS
  These include the shift to targeted therapies which hold the promise of personalized medicine, but also financial pressures, the call for adaptive licensing which places more emphasis on early access and post-authorization studies (patient registries, prospective interventional and observational studies) and real-life effectiveness studies, as well as the emergence of biosimilars in the oncology treatment armamentarium.
authors.affiliation: European Medicines Agency, London, UK. Iordanis.Gravanis@ema.europa.eu.
authors.forename: Iordanis
authors.initials: I
authors.lastname: Gravanis
authors.affiliation: European Medicines Agency, London, UK.
authors.forename: Camille
authors.initials: C
authors.lastname: Vleminckx
authors.affiliation: Läkemedelsverket (Medicinal Products Agency), PO Box 26, SE-751 03 Uppsala, Sweden.
authors.forename: Bertil
authors.initials: B
authors.lastname: Jonsson
authors.affiliation: European Medicines Agency, London, UK.
authors.forename: Francesco
authors.initials: F
authors.lastname: Pignatti
keywords: Personalized medicine; biomarker; biosimilar pharmaceutical; drug approval; molecular targeted therapy