FREE NEJM E-TOC    HOME   |   SUBSCRIBE   |   CURRENT ISSUE   |   PAST ISSUES   |   COLLECTIONS   |   Search Term  Advanced Search

Sign in | Get NEJM's E-Mail Table of Contents — Free | Subscribe

Previous Volume 351:501-505 July 29, 2004 Number 5 Next

	Since this article has no abstract, we have provided an extract of the first 100 words of the full text and any section headings.

	Full Text PDF PDA Full Text Purchase this article Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear PubMed Citation

In the past decade, the primary strategy for discovering new drugs for the treatment of cancer has shifted from screening for cytotoxic compounds to seeking agents that block the key molecular pathways that lead to cancer. A flurry of recent approvals of so-called molecularly targeted agents suggests that this new approach is bearing fruit. However, when the Food and Drug Administration (FDA) approved gefitinib (Iressa) for the treatment of patients with advanced non–small-cell lung cancer in whom both platinum-based and docetaxel (Taxotere) chemotherapy regimens have failed, it was not without controversy. The statistical reviewer for the FDA concluded that the . . . [Full Text of this Article]

The Fast Track

The Lag in Predictive Studies

A Proposal for Selective Approval

Source Information

From the Division of Hematology–Oncology, Massachusetts General Hospital and Harvard Medical School, Boston (T.G.R., B.A.C.); the Program on the Pharmaceutical Industry, Massachusetts Institute of Technology, Cambridge, Mass. (T.G.R.); and the Institute for Technology Assessment, Massachusetts General Hospital, Boston (T.G.R.).

Address reprint requests to Dr. Roberts at Massachusetts General Hospital, Cox 640, 100 Blossom St., Boston, MA 02114, or at troberts@partners.org.

This article has been cited by other articles:

• Labianca, R., Garassino, M., Torri, V. (2008). Predicting response of molecular targeted therapies: a still possible challenge?. Ann Oncol 19: 829-830 [Full Text]  
• Kopetz, S., Overman, M., Chang, D. Z., Glover, K. Y., Shureiqi, I., Wolff, R. A., Abbruzzese, J. L., Eng, C. (2008). Systematic Survey of Therapeutic Trials for Metastatic Colorectal Cancer: Room for Improvement in the Critical Pathway. JCO 26: 2000-2005 [Abstract] [Full Text]  
• De Palma, R., Liberati, A., Ciccone, G., Bandieri, E., Belfiglio, M., Ceccarelli, M., Leoni, M., Longo, G., Magrini, N., Marangolo, M., Roila, F. (2008). Developing Clinical Recommendations for Breast, Colorectal, and Lung Cancer Adjuvant Treatments Using the GRADE System: A Study From the Programma Ricerca e Innovazione Emilia Romagna Oncology Research Group. JCO 26: 1033-1039 [Abstract] [Full Text]  
• Goulart, B. H.L., Clark, J. W., Pien, H. H., Roberts, T. G., Finkelstein, S. N., Chabner, B. A. (2007). Trends in the Use and Role of Biomarkers in Phase I Oncology Trials. Clin. Cancer Res. 13: 6719-6726 [Abstract] [Full Text]  
• Chabner, B. (2007). Phase II Cancer Trials: Out of Control?. Clin. Cancer Res. 13: 2307-2308 [Full Text]  
• Wood, A. J.J. (2006). A Proposal for Radical Changes in the Drug-Approval Process. NEJM 355: 618-623 [Full Text]  
• Workman, P., Aboagye, E. O., Chung, Y.-L., Griffiths, J. R., Hart, R., Leach, M. O., Maxwell, R. J., McSheehy, P. M. J., Price, P. M., Zweit, J. (2006). Minimally invasive pharmacokinetic and pharmacodynamic technologies in hypothesis-testing clinical trials of innovative therapies.. JNCI J Natl Cancer Inst 98: 580-598 [Abstract] [Full Text]  
• Zia, M. I., Siu, L. L., Pond, G. R., Chen, E. X. (2005). Comparison of Outcomes of Phase II Studies and Subsequent Randomized Control Studies Using Identical Chemotherapeutic Regimens. JCO 23: 6982-6991 [Abstract] [Full Text]