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

Table of Contents

Executive Summary

• Overview
• Breast cancer
• Colorectal cancer
• Lung cancer
• Other diseases
• Future outlook

Chapter 1 Overview

• Summary
• Introduction
• The rise of personalized medicine
• Population and disease-based biobanks
• Healthcare costs and R&D productivity
• Applications
• Predictive tests
• Prognostic tests
• Pharmacogenetic tests
• Regulation
• US
• EU
• Regulators response to emerging genomics-based diagnostics

Chapter 2 Breast cancer

• Summary
• Introduction
• Prognostic tests
• MammaPrint
• Oncotype DX
• Uptake of tests
• Other prognostic tests
• Predictive tests
• Hormonal therapies
• Taxanes/anthracyclines
• Biologicals
• Triple negative breast cancer
• Other novel biomarkers

Chapter 3 Colorectal cancer

• Summary
• Introduction
• Prognostic tests
• Predictive tests
• Cetuximab
• Panitumumab
• Other predictive tests

Chapter 4 Lung cancer

• Summary
• Introduction
• Predictive tests
• Gefitinib
• Erlotinib
• Other predictive tests
• Novel therapies

Chapter 5 Other diseases

• Summary
• Prostate cancer
• Ovarian cancer
• Malignant melanoma
• Non-cancer indications
• Cardiovascular diseases
• CNS diseases

Chapter 6 Future outlook

• Summary
• Introduction
• Drug development
• Clinical trial enrichment
• Retrospective study of biomarkers
• The importance of tissue collection
• Coverage and reimbursement

Appendix 139

• Methodology
• Glossary

List of Figures

• Figure 1.1: Cancer cases versus five-year survival, US
• Figure 1.2: Projected health expenditure, 2009-2018, US
• Figure 1.3: New drug approvals and R&D spending, 1996-2008, US
• Figure 1.4: Applications of personalized medicine
• Figure 2.5: Oncotype DX sales ($m), 2004-2008, US
• Figure 2.6: Comparison of Oncotype DX and MammaPrint
• Figure 2.7: Simplified schematic of treatment selection in breast cancer
• Figure 3.8: Development of KRAS as a predictive marker of cetuximab efficacy
• Figure 6.9: Targeted versus non-targeted drug approvals, 1998-2008, US
• Figure 6.10: Clinical trials using predictive biomarkers, 2005-2009
• Figure 6.11: Drivers and resistors to personalized medicine

List of Tables

• Table 1.1: Estimated US cancer cases, by site, 2009
• Table 1.2: Drugs with target specific indications
• Table 1.3: US drug labels with pharmacogenomic information
• Table 2.4: Prognostic breast cancer assays
• Table 2.5: Predictive breast cancer assays
• Table 2.6: Selected ongoing breast cancer trials
• Table 3.7: Selected ongoing colorectal cancer clinical trials
• Table 4.8: Selected ongoing lung cancer clinical trials
• Table 5.9: Selected ongoing miscellaneous clinical trials