Biomarkers in oncology drug development

Regulatory Rapporteur

Volumn 7, Issue 4, 2010, Pages 5-9

  Boulton, Margaret ^a   Dally, Jonathan ^b  

^a Medical and Regulatory Affairs ^*  (United Kingdom)

^b Alliance Pharmaceuticals Limited   (United Kingdom)

Author keywords

Biomarkers; Clinical endpoint; Diagnostic techniques; Oncology; Personalised treatment; Regulatory guidance; Surrogate endpoint

Indexed keywords

ARSENIC TRIOXIDE; BIOLOGICAL MARKER; CETUXIMAB; DASATINIB; EPIDERMAL GROWTH FACTOR RECEPTOR; EPIDERMAL GROWTH FACTOR RECEPTOR 2; ERLOTINIB; IMATINIB; LAPATINIB; NILOTINIB; PANITUMUMAB; RETINOIC ACID RECEPTOR ALPHA; STEM CELL FACTOR RECEPTOR; TRASTUZUMAB;

ACUTE LYMPHOBLASTIC LEUKEMIA; ADVANCED CANCER; BREAST CANCER; BREAST METASTASIS; CHRONIC MYELOID LEUKEMIA; CLINICAL ASSESSMENT; COLORECTAL CANCER; COLORECTAL CARCINOMA; DISEASE MARKER; DRUG DESIGN; DRUG EFFICACY; DRUG SAFETY; GASTROINTESTINAL STROMAL TUMOR; HUMAN; KIRSTEN SARCOMA ONCOVIRUS; LIFE EXPECTANCY; LUNG NON SMALL CELL CANCER; ONCOLOGY; PHARMACOGENOMICS; PHILADELPHIA CHROMOSOME POSITIVE CELL; PRACTICE GUIDELINE; PROMYELOCYTIC LEUKEMIA; REVIEW; TREATMENT PLANNING;

EID: 77953044113     PISSN: 17428955     EISSN: None     Source Type: Trade Journal    
DOI: None     Document Type: Review

References (36)

1. ABPI, 2009. 'The stratification of disease for personalised medicines: Research-driven recommendations from the ABPI'. http://tinyurl.com/yjernk6 (accessed 18 December 2009).
2. Biomarkers Definitions Working Group. 'Biomarkers and surrogate endpoints: preferred definitions and conceptual framework', Clin Pharmacol Ther, 2001;69: 89-95.
3. R Katz. 'Biomarkers and surrogate markers: an FDA perspective', NeuroRx: The Journal of the American Society for Experimental NeuroTherapeutics, 2004;1: 189-195
4. D J Slamon, B Leyland-Jones, S Shak et al. 'Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2', N Engl J Med, 2001;344: 783-792
5. J C Hu and K Mokbel. 'Does c-erbB2/HER2 overexpression predict adjuvant tamoxifen failure in patients with early breast cancer?', Eur J Surg Oncol, 2001;27: 335-337
6. F Rastelli and S Crispino. 'Factors predictive of response to hormone therapy in breast cancer', Tumori, 2008;94: 370-383
7. ClinicalTrials.gov, with search parameters of 'Biomarkers', http://tinyurl.com/ygjkdoh (accessed 4 December 2009).
8. ClinicalTrials.gov - with search parameters of 'Biomarkers and cancer and Phases I & II & III & IV': http://tinyurl.com/yf2kne3, or with search parameters of 'Biomarkers and cancer and Phase I and/or Phase II': http://tinyurl.com/yjk6cz2 (accessed on 4 December 2009).
9. J W Park, R S Kerbel, GJ Kelloff et al. 'Rationale for Biomarkers and Surrogate End Points in Mechanism-Driven Oncology Drug Development', Clin Cancer Res, 2004;10: 3885-3896
10. C H Chau, O Rixe, H McLeod and W D Figg. 'Validation of analytic methods for biomarkers used in drug development', Clin Cancer Res, 2008;14: 5967-5976
11. MISG, 2008. 'Forum on Safety Biomarkers Summary of Discussions and Conclusions', http://tinyurl.com/yl65vsz (accessed 21 December 2009)
12. EMEA, 2009. 'Medicines and Emerging Science - Emerging Technologies'. http://tinyurl.com/ygggk36 (accessed 21 December 2009).
13. EMEA, 2009 (EMEA/151623/2009). 'Report on the EMEA/EFPIA Pharmacogenetics Workshop on Integrating Pharmacogenetics Early into Drug Development: PK as a working example', http://tinyurl.com/yzz3ray (accessed 21 December 2009).
14. EMEA, 2007 (EMEA/522496/2006). 'Report on the EMEA/CHMP Biomarkers Workshop', http://tinyurl.com/ykt35xk (accessed 21 December 2009).
15. EMEA, 2006 (EMEA/CHMP/PGxWP/20227/04). 'Guideline on Pharmacogenetics Briefing Meeting'. (Adopted by CHMP April 2006). http://tinyurl.com/yf5ltzl (accessed 21 December 2009).
16. EMEA, 2006. 'Processing Joint FDA EMEA Voluntary Genomic Data Submissions (VGDSs) within the framework of the Confidentiality Arrangement', http://tinyurl.com/yg5lkxf (accessed 21 December 2009).
17. EMEA, 2007 (EMEA/CPMP/ICH/437986/2006). 'Note for Guidance on Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data And Sample Coding Categories'. http://tinyurl.com/yk74jp2 (accessed 8 January 2010).
18. EMEA, 2009 (EMEA/CHMP/SAWP/72894/2008 Corr1). 'Qualification of Novel Methodologies for Drug Development: Guidance to Applicants', http://tinyurl.com/yks2ow3 (accessed 8 January 2010).
19. EMEA, 2009 (EMEA/CHMP/ICH/380636/2009). 'ICH Topic E16. Genomic Biomarkers Related to Drug Response: Context, Structure and Format of Qualification Submissions'. http://tinyurl.com/ygggk36 (accessed 8 January 2010).
20. EMEA, 2008 (EMEA/ CHMP/PGxWP/128435/06). 'Reflection Paper on Pharmacogenomics in Oncology' (Released for consultation April 2008), http://tinyurl.com/yg53r8z (accessed 21 December 2009).
21. EMEA, 2009. 'Medicines and Emerging Science - Innovation Task Force'. http://tinyurl.com/yh9pku8 (accessed 21 December 2009).
22. EMEA, 2005 (CPMP/EWP/205/95). 'Guideline On The Evaluation Of Anticancer Medicinal Products In Man', http://tinyurl.com/yj22zqa (accessed 18 December 2009).
23. E Abadie (CHMP chair), 2009. 'Regulatory perspectives on Personalized Medicine', http://tinyurl.com/yf7z46r (accessed 8 January 2010).
24. Electronic Medicines Compendium (eMC), 2010. 'Summary of Product Characteristics' for all nine products, http://emc.medicines.org.uk (accessed 16 March 2010).
25. FDA, 2008. 'E15 Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories'. http://tinyurl.com/yz8vm7n (accessed 8 January 2010).
26. FDA, 2008. 'E16 Genomic Biomarkers Related to Drug Response: Context, Structure, and Format of Qualification Submissions', http://tinyurl.com/yfkrng8 (accessed 8 January 2010).
27. FDA CDER, 2005. 'Management of the Interdisciplinary Pharmacogenomics Review Group (IPRG),. http://tinyurl.com/yfl5lzt (accessed 8 January 2010).
28. J R Johnson, G Williams and R Pazdur. 'End points and United States Food and Drug Administration approval of oncology drugs', J Clin Oncol, 2003; 21:1404-1411
29. FDA , 2009. 'Cancer Drugs - Cancer Drug Approval Endpoints', http://tinyurl.com/yhodm2v (accessed 8 January 2010).
30. FDA, 2009. 'Table of Valid Genomic Biomarkers in the Context of Approved Drug Labels', http://tinyurl.com/yhhck65 (accessed 8 January 2010).
31. EMEA and FDA, 2006 (EMEA/191367/2006). 'EU (European Commission and EMEA) and FDA agree on guiding principles for joint FDA EMEA voluntary genomic data submission briefing meetings', http://tinyurl.com/yjqjj4m (accessed 8 January 2010).
32. FDA, 2006. 'Critical Path Opportunities Initiated During 2006', http://tinyurl. com/yjgkdlk (accessed 8 January 2010).
33. EMEA, 2009 (EMEA/585460/2009). 'The European Medicines Agency's participation in Innovative Medicines Initiative (IMI) Research projects'. http://tinyurl.com/yzz3v25 (accessed 8 January 2010).
34. FDA , 2008. 'Oncologic Drugs Advisory Committee Meeting, FDA Briefing Document' dated 16 December 2008, http://tinyurl.com/yz8x748 (accessed 8 January 2010).
35. MISG, 2009. 'Fifth Forum of the Ministerial Industry Strategy Group (MISG) - 9 October 2009', http://tinyurl.com/yjlwcur (accessed 8 January 2010).
36. P Rolan, A J Atkinson Jr, L J Lesko; Scientific Organizing Committee; Conference Report Committee. 'Use of biomarkers from drug discovery through clinical practice: report of the Ninth European Federation of Pharmaceutical Sciences Conference on Optimizing Drug Development', Clin Pharmacol Ther, 2003; 73:284-291