REFERENCES

American Cancer Society. ACS History. 2004; accessed February 18, 2004. Web Page. Available at: http://www.cancer.org/docroot/AA/content/AA_1_4_ACS_History.asp?


Cancer Letter. FDA, CMS take second look at drugs given “accelerated” approval for cancer. The Cancer Letter. 2003 29(12):1–6.

Cancer Letter. Advisors Call for External Oversight, Coordination of NCI Clinical Trials. The Cancer Letter. 2005 31(8):1–7.

Chabner BA. 1990. In defense of cell-line screening. J Natl Cancer Inst 82(13):1083–5.

Chabner, BA, Roberts, TG, Jr. 2005. Chemotherapy and the war on cancer. Nature Reviews/Cancer 5:65–72

Clarke PA, te Poele R, Wooster R et al. 2001. Gene expression microarray analysis in cancer biology, pharmacology, and drug development: progress and potential (Review) (95 refs). Biochem Pharmacol 62(10):1311–36


Dillman RO. 2001. Monoclonal antibodies in the treatment of malignancy: basic concepts and recent developments. [Review] [75 refs]. Cancer Invest 19(8):833–41.

Druker BJ, Talpaz M, Resta DJ et al. 2001 Efficacy and safety of a specific inhibitor of the BCR-ABL tyrosine kinase in chronic myeloid leukemia. New Eng. J. Med. 344(14):1031–37

DTP Program Review Report 1997 Accessed December 27, 2004. Available at http://deainfo.nci.nih.gov/advisory/bsa/bsa_program/bscdevtherprgmin.htm


Eli Lilly and Company. Gemzar (gemcitabine) prescribing information. January 6, 2003; accessed February 17, 2004. Web Page. Available at: http://pi.lilly.com/gemzar.pdf.


Fearon ER, Pardoll DM, Itaya T, Golumbek P, Levitsky HI, Simons JW, Karasuyama H, Vogelstein B, Frost P. 1990. Interleukin-2 production by tumor cells bypasses T helper function in the generation of an antitumor response. Cell. 60 (3):397–403.

Fontanarosa PB, Rennie D, DeAngelis CD. 2004 Postmarketing Surveillance—Lack of Vigilance, Lack of Trust. J. Amer. Med. Assoc. 292(21):2647–50


Genentech. Herceptin (trastuzumab) Patient and Caregiver information. October, 2003; accessed February 17, 2004. Web Page. Available at: http://www.herceptin.com/herceptin/patient/pi.htm.

Giovanella BC, Stehlin JS, Williams LJ Jr. 1974 Heterotransplantation of human malignant tumors in “nude” thymusless mice. II Malignant tumors induced by injection of cell cultures derived from human solid tumors. J. Natl. Cancer Inst. 52(3):921–30

Grever MR, Schepartz SA, Chabner BA. 1992. The National Cancer Institute: cancer drug discovery and development program. [Review] [53 refs]. Semin Oncol 19(6):622–38.


Hanahan D, Weinberg RA. 2000. The hallmarks of cancer. [Review] [94 refs]. Cell 100(1):57–70.

Hirschfeld S, Pazdur R. 2002. Oncology drug development: United States Food and Drug Administration perspective. [Review] [24 refs]. Crit Rev Oncol Hematol 42(2):137–43.

Hollingshead MG, Alley MC, Camalier RF, Abbott BJ, Mayo JG, Malspeis L, Grever



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Federal Agency Roles in Cancer Drug Development from Preclinical Research to New Drug Approval: The National Cancer Institute and the Food and Drug Administration REFERENCES American Cancer Society. ACS History. 2004; accessed February 18, 2004. Web Page. Available at: http://www.cancer.org/docroot/AA/content/AA_1_4_ACS_History.asp? Cancer Letter. FDA, CMS take second look at drugs given “accelerated” approval for cancer. The Cancer Letter. 2003 29(12):1–6. Cancer Letter. Advisors Call for External Oversight, Coordination of NCI Clinical Trials. The Cancer Letter. 2005 31(8):1–7. Chabner BA. 1990. In defense of cell-line screening. J Natl Cancer Inst 82(13):1083–5. Chabner, BA, Roberts, TG, Jr. 2005. Chemotherapy and the war on cancer. Nature Reviews/Cancer 5:65–72 Clarke PA, te Poele R, Wooster R et al. 2001. Gene expression microarray analysis in cancer biology, pharmacology, and drug development: progress and potential (Review) (95 refs). Biochem Pharmacol 62(10):1311–36 Dillman RO. 2001. Monoclonal antibodies in the treatment of malignancy: basic concepts and recent developments. [Review] [75 refs]. Cancer Invest 19(8):833–41. Druker BJ, Talpaz M, Resta DJ et al. 2001 Efficacy and safety of a specific inhibitor of the BCR-ABL tyrosine kinase in chronic myeloid leukemia. New Eng. J. Med. 344(14):1031–37 DTP Program Review Report 1997 Accessed December 27, 2004. Available at http://deainfo.nci.nih.gov/advisory/bsa/bsa_program/bscdevtherprgmin.htm Eli Lilly and Company. Gemzar (gemcitabine) prescribing information. January 6, 2003; accessed February 17, 2004. Web Page. Available at: http://pi.lilly.com/gemzar.pdf. Fearon ER, Pardoll DM, Itaya T, Golumbek P, Levitsky HI, Simons JW, Karasuyama H, Vogelstein B, Frost P. 1990. Interleukin-2 production by tumor cells bypasses T helper function in the generation of an antitumor response. Cell. 60 (3):397–403. Fontanarosa PB, Rennie D, DeAngelis CD. 2004 Postmarketing Surveillance—Lack of Vigilance, Lack of Trust. J. Amer. Med. Assoc. 292(21):2647–50 Genentech. Herceptin (trastuzumab) Patient and Caregiver information. October, 2003; accessed February 17, 2004. Web Page. Available at: http://www.herceptin.com/herceptin/patient/pi.htm. Giovanella BC, Stehlin JS, Williams LJ Jr. 1974 Heterotransplantation of human malignant tumors in “nude” thymusless mice. II Malignant tumors induced by injection of cell cultures derived from human solid tumors. J. Natl. Cancer Inst. 52(3):921–30 Grever MR, Schepartz SA, Chabner BA. 1992. The National Cancer Institute: cancer drug discovery and development program. [Review] [53 refs]. Semin Oncol 19(6):622–38. Hanahan D, Weinberg RA. 2000. The hallmarks of cancer. [Review] [94 refs]. Cell 100(1):57–70. Hirschfeld S, Pazdur R. 2002. Oncology drug development: United States Food and Drug Administration perspective. [Review] [24 refs]. Crit Rev Oncol Hematol 42(2):137–43. Hollingshead MG, Alley MC, Camalier RF, Abbott BJ, Mayo JG, Malspeis L, Grever

OCR for page 56
Federal Agency Roles in Cancer Drug Development from Preclinical Research to New Drug Approval: The National Cancer Institute and the Food and Drug Administration MR. 1995. In vivo cultivation of tumor cells in hollow fibers. Life Sci 57(2):131–41. Johnson DI, Decker S, Zaharevitz D, et al. 2001. Relationships between drug activity in NCI preclinical in vitro and in vivo models and early clinical trials. Br. J. Cancer 84(10):1424–31. Johnson JR, Williams G, Pazdur R. 2003. End points and United States Food and Drug Administration approval of oncology drugs. J Clin Oncol 21 (7):1404–11. Justice RL. 1997. FDA role in cancer drug development and requirements for approval. Teicher BA, editor. Anticancer Drug Development Guide. Totowa, New Jersey: Humana Press. Pp. 293–304. Khleif SN, Curt GA. 2000. Animal models in developmental therapeutics. Bast RC, Gansler TS, Holland JF, Frei E, Editors. Cancer Medicine. 5th ed. Hamilton, Ont.; Lewiston, NY: Decker. Pp. 573–584. Levin, J, Schilsky, R, Burris, H, and et al. 2001. North American Phase III study of oral eniluracil (EU) plus oral 5 fluorouracil (5-FU) versus intravenous (IV) 5FU plus leucovorin (LV) in the treatment of advanced colorectal cancer. Proceedings of ASCO:23. Mininberg, ED, Herbst, RS, Henderson, T, and et al. 2003. Phase I/II study of the recombinant humanized monoclonal anti-VEGF antibody bevacizumab and the EGFR-TK inhibitor erlotinib in patients with recurrent non-small cell lung cancer (NSCLC). ProcASCO:2521. Monks A, Scudiero DA, Johnson GS, Paull KD, Sausville EA. 1997. The NCI anti-cancer drug screen: a smart screen to identify effectors of novel targets. Anticancer Drug Des 12(7):533–41. National Cancer Institute. 2005. Pursuing the Promise of Biomarkers. NCI Cancer Bulletin 2(5):1. National Cancer Institute. 2005. Cancer Research and Regulatory Fellowships Announced. NCI Cancer Bulletin 2(8):16 NCCN National Comprehensive Cancer Network. Clinical Trials Information, accessed October 10, 2003. Web Page. Available at: http://www.nccn.org/. Pardoll D. Presentation to the Committee on Shortening the Time Line for New Cancer Treatments. Washington, D.C.: 2002. Pardoll, D. 2002a. Spinning molecular immunology into successful immunotherapy. Nat. Rev. Immunol. 2(4):227–38 Paull KD, Shoemaker RH, Hodes L, Monks A, Scudiero DA, Rubinstein L, Plowman J, Boyd MR. 1989. Display and analysis of patterns of differential activity of drugs against human tumor cell lines: development of mean graph and COMPARE algorithm. J Natl Cancer Inst 81(14):1088–92. Pazdur, R. 2000. Response Dates, Survival, and Chemotherapy Trials. J. Natl. Cancer Inst. 92(14):1552–3 Petricoin, EF, Zoon, KC, Kohn, EC, et al. 2004. Clinical Proteomics: Translating Benchside Promise into Bedside Reality. Nature Reviews Proteomics Collection, September:20–32 Plaister MK. Letter to Honorable Thomas J Bliley Jr, Chairman Committee on Commerce House of Representatives. 2000 June 13. Plowman J, Dykes BS, Hollingshead M et al., 1997 Human tumor xenograft models in

OCR for page 56
Federal Agency Roles in Cancer Drug Development from Preclinical Research to New Drug Approval: The National Cancer Institute and the Food and Drug Administration NCI drug development in Anticancer Drug Development Guide, Teicher BA editor. Humana Press, Totowa, New Jersey Roberts, TG, Jr., Chabner, BA. 2004. Beyond Fast Track for Drug Approvals. New Eng. J. Med. 351(5):501–5 Roberts, TG, Jr., Hirschfeld, S. Food and Drug Administration Role in Oncology Product Development in Chabner, BA and Longo, DL, Cancer Chemotherapy and Biotherapy: Principles and Practice, Fourth Edition, Lippincott Williams and Wilkins, Phila, Pa, 2005 Ross DT, Scherf U, Eisen MB, Perou CM, Rees C, Spellman P, Iyer V, Jeffrey SS, Van de Rijn M, Waltham M, Pergamenschikov A, Lee JCF, Lashkari D, Shalon D, Myers TG, Weinstein JN, Botstein D, Brown PO. 2000. Systematic variation in gene expression patterns in human cancer cell lines. Nat Genet 24(3):227–235. Sanofi-Synthelabo. Eloxatin Prescribing Information. August, 2002; accessed February 17, 2004. Web Page. Available at: http://www.sanofi-synthelabous.com/products/index.html#. Sargent DJ, Niedzwiecki D, O’Connell MJ, Schilsky RL, Ledermann JA, Leonard P, Seymour M, Miller LL. 2001. Recommendation for caution with irinotecan, fluorouracil, and leucovorin for colorectal cancer [1] (multiple letters). New England Journal of Medicine. Vol. 345 (2):144–146. Sausville EA, Feigal E. 1999. Evolving approaches to cancer drug discovery and development at the National Cancer Institute, USA. [Review] [6 refs]. Ann Oncol Sausville EA, Johnson JI. 2000. Molecules for the millennium: how will they look? New drug discovery year 2000. Br J Cancer 83(11):1401–4. Schabel, FM Jr., Skipper, HE, Trader, MW et al. 1969 Spontaneous AK leukemia (lymphoma) as a model system. Cancer Chemother. Rep. 53 (6):3 29–44. Schein PS. 2001. The case for a new national program for the development of cancer therapeutics. J Clin Oncol 19(12):3142–53. Schilsky R. Presentation to the Committee on Shortening the Time Line for New Cancer Treatments. Washington, D.C.: 2002. Schilsky RL. Hurry up and wait: Is accelerated approval of new cancer drugs in the best interests of cancer patients? J Clin Oncol 2003; 21(20):3718–20. Sherwood P. New Agents for Treating Cancer: Expanding the Pipeline and Shortening the Timeline. Background paper for the committee. October 2003 Shulman SR, Kaitin KI. 1996. The Prescription Drug User Fee Act of 1992. A 5-year experiment for industry and the FDA. [Review] [46 refs]. Pharmacoeconomics 9(2):121–33. Skipper, HE, Schabel, FM Jr., Mellet LB, et al. 1970 Implications of biochemical, cytoknetic, pharmacologic, and toxicologic relationships in the design of optimal therapeutic schedules. Cancer Chemothe. Rep. 54(6):431–50 Temple R. Commentary on “The Architecture of Government Regulation of Medical Products”. Virginia Law Review . 1996; 82(8):1879. U.S. Department of Health and Human Services/ Food and Drug Administration. 2004. Challenge and Opportunity of the Critical Path to New Medical Products U.S. Food and Drug Administration, Center for Drug Evaluation and Research. FDA’s Drug Review and Approval Times. accessed May 28, 2002b. Web Page.

OCR for page 56
Federal Agency Roles in Cancer Drug Development from Preclinical Research to New Drug Approval: The National Cancer Institute and the Food and Drug Administration Available at: http://www.fda.cder/reports/reviewtimes/default.htm. U.S. Food and Drug Administration. Guidance for Industry: Antiretroviral Drugs Using Plasma HIV RNA Measurements Clinical Considerations for Accelerated and Traditional Approval. October, 2002c; accessed February 17, 2004c. Web Page. Available at: http://www.fda.gov/cder/guidance/3647fnl.doc U.S. Food and Drug Administration. FDA Guidance for Industry. Providing Clinical Evidence of Effectiveness for Human Drugs and Biological Products. May, 1998. at: http://www.fda.gov/cder/guidance/1397fnl.pdf. U.S. Food and Drug Administration. Guidance for Industry: Providing Clinical Evidence of Effectiveness for Human Drug and Biological Products. Clinical 6. 1998. U.S. Food and Drug Administration. Guidance for Industry: Special Protocol Assessment. Rockville, MD: U.S. Food and Drug Administration, Center for Drug Evaluation and Research; 2002a. U.S. Food and Drug Administration. Improving Innovation in Medical Technology: Beyond 2002. accessed July 15, 2003a. Web Page. Available at: http://www.fda.gov/bbs/topics/news/2003/bevond2002/report.html. U.S. Food and Drug Administration. Office of Combination Products, accessed February 17, 2004. Web Page. Available at: http://www.fda.gov/oc/combination. U.S. Food and Drug Administration. 2002 Workshop on Pharmacogenetics and Pharmacogenomics in Drug Development and Regulatory Decision-Making. May 16, 2002b-May 17, 2002b; accessed February 17, 2004b. at: http://www.fda.gov/cder/calendar/meeting/phrma52002/workbook.pdf. U.S. General Accounting Office. 2002 Food and Drug Administration: Effect of User Fees on Drug Approval Times, Withdrawals, and Other Agency Activities. Washington, DC: General Accounting Office; Publication GAO-02–958 Venditti, J.M. 1981. Preclinical drug development: rationale and methods. Seminars in Oncology 8, no. 4:349–61. Venditti, J.M., R.A.Wesley, and J.Plowman. 1984. Current NCI preclinical antitumor screening in vivo: results of tumor panel screening, 1976–1982, and future directions. [Review] [43 refs]. Advances in Pharmacology & Chemotherapy 20: 1–20. Von Pawel J, Von Roemeling R, Gatzemeier U, Boyer M, Elisson LO, Clark P, Talbot D, Rey A, Butler TW, Hirsh V, Olver I, Bergman B, Ayoub J, Richardson G, Dunlop D, Arcenas A, Vescio R, Viallet J, Treat J. 2000. Tirapazamine plus cisplatin versus cisplatin in advanced non-small-cell lung cancer: A report of the international CATAPULT I study group. Journal of Clinical Oncology. Vol. 18 (6):1351–1359. Wang RF, Wang HY. 2002. Enhancement of antitumor immunity by prolonging antigen presentation on dendritic cells. Nature Biotechnology. Vol. 20 (2): 149–154. Weinstein JN, Myers TG, O’Connor PM, Friend SH, Fornace AJ Jr, Kohn KW, Fojo T, Bates SE, Rubinstein LV, Anderson NL, Buolamwini JK, van Osdol WW, Monks AP, Scudiero DA, Sausville EA, Zaharevitz DW, Bunow B, Viswanadhan VN, Johnson GS, Wittes RE, Paull KD. 1997. An information-intensive approach to the molecular pharmacology of cancer. Science 275(5298):343–9. Zubrod CG, Schepartz SA, Carter SK. 1977. Historical background of the National Cancer Institute’s drug development thrust. Natl Cancer Inst Monogr (45):7–11.

OCR for page 56
Federal Agency Roles in Cancer Drug Development from Preclinical Research to New Drug Approval: The National Cancer Institute and the Food and Drug Administration Zubrod CG. 1984. Origins and development of chemotherapy research at the National Cancer Institute. Cancer Treat Rep 68(1):9–19.