Predictive biomarkers in advance of a companion drug: Ahead of their time?

JNCCN Journal of the National Comprehensive Cancer Network

Volumn 10, Issue 3, 2012, Pages 303-309

  Kelley, Robin K ^a   Atreya, Chloe ^a   Venook, Alan P ^a   Febbo, Phillip G ^a  

^a UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

Biomarker; Companion diagnostic device; In vitro device; Predictive; Targeted therapy

Indexed keywords

BIOLOGICAL MARKER; TUMOR MARKER;

ARTICLE; GENETIC ANALYSIS; HUMAN; MOLECULAR DIAGNOSIS; PREDICTION; RISK; VALIDATION PROCESS;

EID: 84858275121     PISSN: 15401405     EISSN: 15401413     Source Type: Journal    
DOI: 10.6004/jnccn.2012.0031     Document Type: Article

References (29)

1. Draft Guidance for Industry and Food and Drug Administration Staff - In Vitro Companion Diagnostic Devices. FDA Web site. Available at: http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ ucm262292.htm. Accessed January 23, 2012.
2. Simon R. Clinical trial designs for evaluating the medical utility of prognostic and predictive biomarkers in oncology. Per Med 2010;7:33-47.
3. Gutman S, Kessler LG. The US Food and Drug Administration perspective on cancer biomarker development. Nat Rev Cancer 2006;6:565-571. (Pubitemid 43980545)
4. Saah AJ, Hoover DR. "Sensitivity" and "specificity" reconsidered: the meaning of these terms in analytical and diagnostic settings. Ann Intern Med 1997;126:91-94. (Pubitemid 27021232)
5. Stratton MR. Exploring the genomes of cancer cells: progress and promise. Science 2011;331:1553-1558.
6. Khleif SN, Doroshow JH, Hait WN. AACR-FDA-NCI Cancer Biomarkers Collaborative consensus report: advancing the use of biomarkers in cancer drug development. Clin Cancer Res 2010;16:3299-3318.
7. McClellan M, Benner J, Schilsky R, et al. An accelerated pathway for targeted cancer therapies. Nat Rev Drug Discov 2011;10:79-80.
8. Nass SJ, Balogh E, Mendelsohn J. A National Cancer Clinical Trials Network: recommendations from the Institute of Medicine. Am J Ther 2011;18:382-391.
9. Chapman PB, Hauschild A, Robert C, et al. Improved survival with vemurafenib in melanoma with BRAF V600E mutation. N Engl J Med 2011;364:2507-2516.
10. Douillard JY, Shepherd FA, Hirsh V, et al. Molecular predictors of outcome with gefitinib and docetaxel in previously treated non-small-cell lung cancer: data from the randomized phase III INTEREST trial. J Clin Oncol 2010;28:744-752.
11. Kwak EL, Bang YJ, Camidge DR, et al. Anaplastic lymphoma kinase inhibition in non-small-cell lung cancer. N Engl J Med 2010;363:1693-1703.
12. Tsimberidou AM, Iskander NG, Hong DS, et al. Personalized medicine in a phase I clinical trials program: the M. D. Anderson Cancer Center initiative [abstract]. J Clin Oncol 2011;28(Supp 1):Abstract CRA2500.
13. Wistuba II, Gelovani JG, Jacoby JJ, et al. Methodological and practical challenges for personalized cancer therapies. Nat Rev Clin Oncol 2011;8:135-141.
14. Li C. Personalized medicine - the promised land: are we there yet? Clin Genet 2011;79:403-412.
15. Raman G, Wallace B, Patel K, et al. Update on horizon scans of genetic tests currently available for clinical use in cancers. Available at: https://www.cms.gov/determinationprocess/downloads/id81TA.pdf. Accessed January 23, 2012.
16. Hoggatt J. Personalized medicine - trends in molecular diagnostics: exponential growth expected in the next ten years. Mol Diagn Ther 2011;15:53-55.
17. Feldman MD, Petersen AJ, Karliner LS, et al. Who is responsible for evaluating the safety and effectiveness of medical devices? The role of independent technology assessment. J Gen Intern Med 2008;23(Suppl 1):57-63. (Pubitemid 350295392)
18. Phillips KA, Van Bebber SL. Regulatory perspectives on pharmacogenomics: a review of the literature on key issues faced by the United States Food and Drug Administration. Med Care Res Rev 2006;63:301-326. (Pubitemid 43667961)
19. Control of direct-to-consumer genetic testing. Lancet 2008;372:1360.
20. Overview of IVD Regulation. U.S. Food and Drug Adminstration Web site. Available at: http://www.fda.gov/medicaldevices/deviceregulationandguidance/ ivdregulatoryassistance/ucm123682.htm. Accessed January 23, 2012.
21. Vaught J, Rogers J, Myers K, et al. An NCI perspective on creating sustainable biospecimen resources. J Natl Cancer Inst Monogr 2011;2011:1-7.
22. Kopetz S, Desai J, Chan E, et al. PLX4032 in metastatic colorectal cancer patients with mutant BRAF tumors [abstract]. J Clin Oncol 2010;28(Suppl 1):Abstract 3534.
23. De Roock W, Jonker DJ, Di Nicolantonio F, et al. Association of KRAS p.G13D mutation with outcome in patients with chemotherapy-refractory metastatic colorectal cancer treated with cetuximab. JAMA 2010;304:1812-1820.
24. Tejpar S, Bokemeyer C, Celik I, et al. Influence of KRAS G13D mutations on outcome in patients with metastatic colorectal cancer (mCRC) treated with first-line chemotherapy with or without cetuximab [abstract]. J Clin Oncol 2011;29(Suppl 1):Abstract 3511.
25. Paxton A. Molecular CPT codes topple old 'stacking' codes. College of American Pathologists Web site. Available at: http://www.cap.org/apps/cap. portal?-nfpb=true&cntvwrPtlt-actionOverride= %2Fportlets%2FcontentViewer%2Fshow&-windowLabel=cntvwrPtlt& cntvwrPtlt%7BactionForm.contentReference%7D=cap-today%2F0411%2F0411d-molecular- cpt.html&-state=maximized&-pageLabel=cntvwr. Accessed January 23, 2012.
26. Haga SB, Willard HF. Defining the spectrum of genome policy. Nat Rev Genet 2006;7:966-972. (Pubitemid 44871400)
27. Kontos EZ, Viswanath K. Cancer-related direct-to-consumer advertising: a critical review. Nat Rev Cancer 2011;11:142-150.
28. Mendelsohn J. A national cancer clinical trials system for targeted therapies. Sci Transl Med 2011;3:75cm8.
29. Goodsaid FM, Frueh FW, Mattes W. Strategic paths for biomarker qualification. Toxicology 2008;245:219-223.