title: Tamoxifen for the reduction in the incidence of breast cancer in women at high risk for breast cancer.
abstract: Recent legislation, including the Prescription Drug User Fee Act (1992) and the FDA Modernization Act (FDAMA) (1997), has provided an environment in which new drug applications (NDA) can be efficiently reviewed, resulting in rapid access to new drugs or to new uses for approved drugs by the public. The recent submission of a supplemental NDA for tamoxifen for the reduction in the incidence of breast cancer in women at high risk for breast cancer is an excellent example of the application of this legislation. First, the application received expedited but thorough multidisciplinary and interdivisional review by the FDA. Second, it required collaboration between the manufacturer (AstraZeneca Pharmaceuticals), the National Surgical Adjuvant Breast and Bowel Project (NSABP), the National Cancer Institute (NCI), and the FDA. This process worked well and demonstrated that cooperative group data can be used effectively to support an application. Third, a single large adequate and well-controlled trial was sufficient to support the effectiveness of tamoxifen for this indication. The quantity of evidence required to support approval has been discussed in FDA guidances ("Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products") and is part of FDAMA.
authors.affiliation: Division of Oncology Drug Products, United States Food and Drug Administration, Rockville, Maryland 20852, USA. honigs@cder.fda.gov
authors.forename: S F
authors.initials: SF
authors.lastname: Honig
mesh_terms: D000972:Antineoplastic Agents, Phytogenic / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000453:epidemiology / Q000517:prevention & control*; D005260:Female; D006077:Government Agencies; D006801:Humans; D015994:Incidence; D012307:Risk Factors; D020845:Selective Estrogen Receptor Modulators / Q000592:standards / Q000627:therapeutic use*; D013629:Tamoxifen / Q000627:therapeutic use*; D014481:United States / Q000453:epidemiology; D014486:United States Food and Drug Administration
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D020845:Selective Estrogen Receptor Modulators; D013629:Tamoxifen