1. Regulatory approval of cancer risk-reducing (chemopreventive) drugs: moving what we have learned into the clinic.
- Author
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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, and Szabo, Eva
- Subjects
Anticarcinogenic Agents: pharmacology ,Breast Neoplasms: metabolism ,Chemoprevention: methods ,Clinical Trials as Topic ,Drug Approval ,Drug Industry: methods ,Early Detection of Cancer ,Female ,Humans ,Male ,Medical Oncology: methods ,Neoplasms: prevention & control ,Patient Compliance ,Risk ,Tumor Markers ,Biological: metabolism ,adenosine A2 receptor agonist ,alpha adrenergic receptor blocking agent ,angiotensin 2 receptor antagonist ,antineoplastic agent ,BCG vaccine ,beta adrenergic receptor blocking agent ,biological marker ,calcium channel blocking agent ,cancer vaccine ,celecoxib ,cyclooxygenase 2 inhibitor ,diclofenac ,dipeptidyl carboxypeptidase inhibitor ,diuretic agent ,finasteride ,ganglion blocking agent ,guanethidine ,hormone inhibitor ,hydralazine ,monoamine oxidase inhibitor ,nonsteroid antiinflammatory agent ,photofrin ,placebo ,raloxifene ,retinoid derivative ,sulindac ,tamoxifen ,thiocyanic acid derivative ,Veratrum alkaloid ,Wart virus vaccine ,actinic keratosis ,adenoma ,antihypertensive therapy ,Barrett esophagus ,bladder carcinoma ,breast cancer ,cancer invasion ,cancer prevention ,cancer risk ,carcinoma in situ ,cardiovascular disease ,catecholamine depletion ,clinical practice ,conceptual framework ,disease severity ,drug approval ,drug cost ,drug industry ,drug research ,drug synthesis ,familial adenomatous polyposis ,familial polyposis ,genetic risk ,human ,hypertension ,low drug dose ,neoplasm ,note ,priority journal ,prostate cancer ,randomized controlled trial (topic) ,risk reduction ,single nucleotide polymorphism ,United States ,uterine cervix cancer ,Anticarcinogenic Agents ,Breast Neoplasms ,Chemoprevention ,Clinical Trials as Topic ,Drug Approval ,Drug Industry ,Early Detection of Cancer ,Female ,Humans ,Male ,Medical Oncology ,Neoplasms ,Patient Compliance ,Risk ,Tumor Markers ,Biological - Abstract
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.
- Published
- 2011