Expanding Applications of Personalized Medicine

Use of Biomarkers in Prognostic, Predictive and Pharmacogenetic Tests in a Targeted Approach

Publication Date	August 2009
Publisher	Business Insights
Product Type	Report
Pages	141
ISBN Number	not applicable
Product Code	RBI00328

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Summary

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.

Content

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
- Conclusion
- Appendix
- 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