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Regulatory approval of cancer risk-reducing (chemopreventive) drugs: moving what we have learned into the clinic.

  • Author(s): Meyskens, Frank L, Jr
  • Curt, Gregory A
  • Brenner, Dean E
  • Gordon, Gary
  • Herberman, Ronald B
  • Finn, Olivera
  • Kelloff, Gary J
  • Khleif, Samir N
  • Sigman, Caroline C
  • Szabo, Eva
  • et al.

This article endeavors to clarify the current requirements and status of regulatory approval for chemoprevention (risk reduction) drugs and discusses possible improvements to the regulatory pathway for chemoprevention. Covering a wide range of topics in as much depth as space allows, this report is written in a style to facilitate the understanding of nonscientists and to serve as a framework for informing the directions of experts engaged more deeply with this issue. Key topics we cover here are as follows: a history of definitive cancer chemoprevention trials and their influence on the evolution of regulatory assessments; a brief review of the long-standing success of pharmacologic risk reduction of cardiovascular diseases and its relevance to approval for cancer risk reduction drugs; the use and limitations of biomarkers for developing and the approval of cancer risk reduction drugs; the identification of individuals at a high(er) risk for cancer and who are appropriate candidates for risk reduction drugs; business models that should incentivize pharmaceutical industry investment in cancer risk reduction; a summary of scientific and institutional barriers to development of cancer risk reduction drugs; and a summary of major recommendations that should help facilitate the pathway to regulatory approval for pharmacologic cancer risk reduction drugs.

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