Expanding Applications of Personalized Medicine: Use of biomarkers in prognostic, predictive and pharmacogenetic tests in a targeted approach - 2009/08/01 - Business Insights

Report title: Expanding Applications of Personalized Medicine: Use of biomarkers in prognostic, predictive and pharmacogenetic tests in a targeted approach

from Business Insights
141 page report published Aug 01, 2009

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Personalized medicine is the tailoring of medical treatment to specific groups of patients, rather than to the population as a whole. Over the past decade, several significant advances in targeted therapies have improved the ability to treat certain cancers, the most notable early successes been trastuzumab in breast cancer and imatinib in chronic myelogenous leukaemia. Recently, several important breakthroughs have occurred, including the identification of a mechanism of resistance to EGFR monoclonal antibodies in colorectal cancer, which may be followed by further predictive tests leading to a reduction in the use of ineffective therapies. The number of drugs with pharmacogenomic recommendations in product labels is steadily increasing, widening the application of personalized medicine to individualize treatments beyond cancer. Although investment in personalized medicine is beginning to show valuable results, its integration into routine clinical practice has been slow and it currently does not impact the care of the vast majority of patients. To widen the benefits of personalized medicine over the next ten years, several obstacles need to be overcome, including increased regulatory burden, lack of reimbursement, demonstration of clinical utility and integration into drug development.

Source:

Business Insights

Document ID:

rbhc0235

Industry:

Health Care

Industry:

Pharmaceutical

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Title	Starting Page	Number of Pages
Sections
Table of Contents Expanding applications of personalized medicine Executive Summary 8 Overview 8 Breast cancer 8 Colorectal cancer 9 Lung cancer 10 Other diseases 11 Future outlook 12 Chapter 1 Overview 14 Summary 14 Introduction 15 The rise of personalize	0	1
Table of Contents	0	1
Expanding applications of personalized medicine	0	1
Executive Summary 8	0	1
Overview 8	0	1
Breast cancer 8	0	1
Colorectal cancer 9	0	1
Lung cancer 10	0	1
Other diseases 11	0	1
Future outlook 12	0	1
Chapter 1 Overview 14	0	1
Summary 14	0	1
Introduction 15	0	1
The rise of personalized medicine 16	0	1
Population and disease-based biobanks 17	0	1
Healthcare costs and R&D productivity 22	0	1
Applications 24	0	1
Predictive tests 25	0	1
Prognostic tests 27	0	1
Pharmacogenetic tests 28	0	1
Regulation 32	0	1
US 32	0	1
EU 34	0	1
Regulators response to emerging genomics-based diagnostics 34	0	1
Chapter 2 Breast cancer 40	0	1
Summary 40	0	1
Introduction 41	0	1
Prognostic tests 41	0	1
MammaPrint 42	0	1
Oncotype DX 43	0	1
Uptake of tests 45	0	1
Other prognostic tests 50	0	1
Predictive tests 55	0	1
Hormonal therapies 55	0	1
Taxanes/anthracyclines 59	0	1
Biologicals 63	0	1
Triple negative breast cancer 65	0	1
Other novel biomarkers 69	0	1
Chapter 3 Colorectal cancer 74	0	1
Summary 74	0	1
Introduction 75	0	1
Prognostic tests 75	0	1
Predictive tests 78	0	1
Cetuximab 78	0	1
Panitumumab 83	0	1
Other predictive tests 87	0	1
Chapter 4 Lung cancer 92	0	1
Summary 92	0	1
Introduction 93	0	1
Predictive tests 93	0	1
Gefitinib 93	0	1
Erlotinib 96	0	1
Other predictive tests 99	0	1
Novel therapies 101	0	1
Chapter 5 Other diseases 106	0	1
Summary 106	0	1
Prostate cancer 107	0	1
Ovarian cancer 109	0	1
Malignant melanoma 110	0	1
Non-cancer indications 112	0	1
Cardiovascular diseases 113	0	1
CNS diseases 116	0	1
Chapter 6 Future outlook 120	0	1
Summary 120	0	1
Introduction 121	0	1
Drug development 121	0	1
Clinical trial enrichment 121	0	1
Retrospective study of biomarkers 126	0	1
The importance of tissue collection 130	0	1
Coverage and reimbursement 134	0	1
Conclusion 137	0	1
Appendix 139	0	1
Methodology 139	0	1
Glossary 140	0	1
List of Figures	0	1
Figure 1.1: Cancer cases versus five-year survival, US 20	0	1
Figure 1.2: Projected health expenditure, 2009-2018, US 22	0	1
Figure 1.3: New drug approvals and R&D spending, 1996-2008, US 23	0	1
Figure 1.4: Applications of personalized medicine 24	0	1
Figure 2.5: Oncotype DX sales ($m), 2004-2008, US 46	0	1
Figure 2.6: Comparison of Oncotype DX and MammaPrint 49	0	1
Figure 2.7: Simplified schematic of treatment selection in breast cancer 64	0	1
Figure 3.8: Development of KRAS as a predictive marker of cetuximab efficacy 81	0	1
Figure 6.9: Targeted versus non-targeted drug approvals, 1998-2008, US 123	0	1
Figure 6.10: Clinical trials using predictive biomarkers, 2005-2009 127	0	1
Figure 6.11: Drivers and resistors to personalized medicine 133	0	1
List of Tables	0	1
Table 1.1: Estimated US cancer cases, by site, 2009 21	0	1
Table 1.2: Drugs with target specific indications 26	0	1
Table 1.3: US drug labels with pharmacogenomic information 30	0	1
Table 2.4: Prognostic breast cancer assays 51	0	1
Table 2.5: Predictive breast cancer assays 59	0	1
Table 2.6: Selected ongoing breast cancer trials 67	0	1
Table 3.7: Selected ongoing colorectal cancer clinical trials 84	0	1
Table 4.8: Selected ongoing lung cancer clinical trials 99	0	1
Table 5.9: Selected ongoing miscellaneous clinical trials 111	0	1

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