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Biomarker and Diagnostic Opportunities Associated with Targeted Cancer Therapies
Decision Resources, Inc., Dec 2009, Pages: 34
The influence of biomarkers in oncology has extended to just about every aspect of the drug-diagnostic relationship in the therapeutic area. Biomarkers are used to help streamline clinical trials, stratify patient populations, monitor and inform drug safety and efficacy, provide information on disease progression, and aid in the diagnosis of a cancer. The critical role of biomarkers in targeted cancer therapies is underscored by oncologists we surveyed for this report and ongoing clinical research. The surveyed oncologists identified the most important unmet needs in the area and revealed which oncology indication has the most potential for a successful targeted therapy with the development of an associated companion diagnostic test.
Questions Answered in this Report
- Biomarkers are increasingly being incorporated into cancer drug development because of their ability to identify appropriate patients for treatment. How have biomarkers enabled the approval of many of today’s successful targeted therapies, such as Genentech/Roche/Chugai’s Herceptin for breast cancer and Novartis’s Gleevec for chronic myelogenous leukemia?
- Merck & Co., Eli Lilly, Novartis, Roche, and Pfizer are examples of pharmaceutical companies that have numerous programs in drug development with companion diagnostics. How can diagnostics companies capitalize on pharma’s interest in diagnostic-therapeutic partnerships in the quest to make the preclinical and clinical development processes more efficient?
- Oncologists surveyed by Decision Resources agree that the availability of a clinically validated biomarker is a key element in determining which diagnostic test they choose to use. What does validation of biomarkers entail? How do biomarkers influence physician prescribing of targeted oncology therapies?
- Genetic markers, such as Her2/Neu and BCR-ABL and genetic mutations in EGFR and KRAS, are integral in the design of targeted therapies. Which markers and associated drugs are currently being studied in clinical trials?
- Diagnostic imaging technologies are used by oncologists in diagnosing cancers and in monitoring disease activity. Which modality is most commonly used by oncologists surveyed by Decision Resources? How does that compare with recommendations from researchers and with the current clinical trial activity?
Scope
- Analysis of primary research: Survey results from 224 U.S. oncologists; 79 biomarker and diagnostics deals; 635 clinical trials; insight from Decision Resources analysts.
- Indications: Breast, colorectal, and lung cancers; leukemias and lymphomas; other high-interest cancers for which targeted therapies are being explored.
- Spectrum Expert Commentary: George S. Mack, D.M.D., describes the irresistible value of using biomarkers in drug development and discusses key opportunities on the horizon.
- Outlook: Forward-looking view supported by survey findings and clinical trial results regarding areas of focus for biomarker research that pharmaceutical and diagnostics companies should consider.
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