Impact of biomarker usage on oncology drug development

Journal of Clinical Pharmacy and Therapeutics

Volumn 38, Issue 1, 2013, Pages 62-67

  Hayashi, K ^a,b   Masuda, S ^a   Kimura, H ^a  

^a UNIVERSITY OF TOKYO   (Japan)

^b Japan Pharmaceutical Manufacturers Association   (Japan)

Author keywords

biomarker; drug development; oncology; research and development

Indexed keywords

ANTINEOPLASTIC AGENT; PHARMACOLOGICAL BIOMARKER;

ARTICLE; CLINICAL STUDY; CLINICAL TRIAL (TOPIC);

ANTINEOPLASTIC AGENTS; BIOLOGICAL MARKERS; CLINICAL TRIALS AS TOPIC; DRUG DESIGN; DRUG INDUSTRY; HUMANS; NEOPLASMS; ORPHAN DRUG PRODUCTION;

EID: 84871999001     PISSN: 02694727     EISSN: 13652710     Source Type: Journal    
DOI: 10.1111/jcpt.12008     Document Type: Article

References (18)

1. DiMasi JA, Hansen RW, Grabowski HG. The price of innovation: new estimates of drug development costs. J Health Econ, 2003;22:151-185. (Pubitemid 36279392)
2. Adams CP, Brantner VV. Spending on new drug development. Health Econ, 2010;19:130-141.
3. Paul SM, Mytelka DS, Dunwiddie CT et al. How to improve R&D productivity: the pharmaceutical industry's grand challenge. Nat Rev Drug Discov, 2010;9:203-214.
4. Hayashi K, Masuda S, Kimura H. Analyzing global trends of biomarker use in drug interventional clinical studies. Drug Discov Ther, 2012;6:102-107.
5. Food and Drug Administration. Innovation or stagnation: challenge and opportunity on the critical path to new medical products. March, 2004. Available at: http:// www.fda.gov/ScienceResearch/Special-Topics/CriticalPathInitiative/ Critical-PathOpportunitiesReports/ucm077262.htm (accessed 30 July, 2012).
6. Dieterle F, Sistare F, Goodsaid F et al. Renal biomarker qualification submission: a dialog between the FDA-EMEA and Predictive Safety Testing Consortium. Nat Biotechnol, 2010;28:455-462.
7. Mason A, Drummond M, Ramsey S, Campbell J, Raisch D. Comparison of anticancer drug coverage decisions in the United States and United Kingdom: does the evidence support the rhetoric? J Clin Oncol, 2010;28:3234-3238.
8. Innocenti F, Undevia SD, Iyer L et al. Genetic variants in the UDP-glucuronosyltransferase 1A1 gene predict the risk of severe neutropenia of irinotecan. J Clin Oncol, 2004;22:1382-1388. (Pubitemid 41103619)
9. Food and Drug Administration. Draft guidance for industry and FDA staff - in vitro companion diagnostic devices. 14 July, 2011. Available at: http://www.fda.gov/ MedicalDevices/DeviceRegulationand-Guidance/ GuidanceDocuments/ ucm262292.htm (accessed 30 July, 2012).
10. Kaitin KI, DiMasi JA. Pharmaceutical innovation in the 21st Century: new drug approvals in the first decade, 2000-2009. Clin Pharmacol Ther, 2011;89:183-188.
11. DiMasi JA, Feldman L, Seckler A, Wilson A. Trends in risks associated with new drug development: success rates for investigational drugs. Clin Pharmacol Ther, 2010;87:272-277.
12. Walker I, Newell H. Do molecularly targeted agents in oncology have reduced attrition rates? Nat Rev Drug Discov, 2009;8:15-16.
13. Kola I, Landis J. Can the pharmaceutical industry reduce attrition rates? Nat Rev Drug Discov, 2004;3:711-715. (Pubitemid 39173511)
14. Nelson AL, Dhimolea E, Reichert JM. Development trends for human monoclonal antibody therapeutics. Nat Rev Drug Discov, 2010;9:767-774.
15. Arrowsmith J. Phase III and submission failures: 2007-2010. Nat Rev Drug Discov, 2010;10:87.
16. Mok TS, Wu YL, Thongprasert S et al. Gefinitib or carboplatin-paclitaxel in pulmonary adenocarcinoma. N Engl J Med, 2009;361:947-957.
17. Cutsem EV, Köhne CH, Hitre E et al. Cetuximab and chemotherapy as initial treatment for metastatic colorectal cancer. N Engl J Med, 2009;360:1408-1417.
18. Cutsem EV, Peeters M, Siena S et al. Open-label phase III trial of panitumumab plus best supportive care compared with best supportive care alone in patients with chemotherapy-refractory metastatic colorectal cancer. J Clin Oncol, 2007;25:1658-1664. (Pubitemid 46797944)