"The emerging use of cancer biomarkers may herald an era in which physicians no longer make treatment choices that are based on population statistics, but rather on the specific characteristics of individual patients and their tumor."
Cancer Biomarkers: An Invitation to the Table, Science, May 26, 2006, William Dalton and Stephen Friend
"These new drugs will be more cancer/patient-specific and will have the potential for slowing cancer growth and inhibiting disease progression, with fewer adverse side effects on the patient. As these drugs come to market, in vitro diagnostics will become critical to matching drug to cancer and to patient and then the monitoring of the drug’s action on the disease.”
The Worldwide Market of Cancer Diagnostics, Kalorama Information, 10/2005
"A description of cancer in molecular terms seems increasingly likely to improve the ways in which human cancers are detected, classified monitored, and (especially) treated."
Harold Varmus, The New Era of Cancer Research, Science 26 May 2006, Vol. 312
|
At the turn of the 21st century, there is a dramatic shift toward personalized medicine where an individual’s unique molecular characteristics will dictate medical treatment. These molecular characteristics, called biomarkers, may be found in the bloodstream, tumors or other tissues and include molecules such as DNA, RNA and proteins. A biomarker is “a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention.” (Biomarkers and Surrogate Endpoints: Preferred Definitions and Conceptual Framework,” Clinical Pharmacology & Therapeutics, Vol. 69, Number 3, March 2001.)
Biomarkers are increasingly being utilized to guide the biopharmaceutical industry’s drug development efforts, particularly the new category of drugs called targeted cancer therapeutics. Simultaneously, the parallel development of a new targeted cancer drug with a molecular diagnostic test, known as “drug-diagnostic co-development” or “companion diagnostics,” is a new paradigm being encouraged by the FDA through its Critical Path Initiative.
Simultaneously, the field of oncology will be driven by the need to manage combination drug therapies related to the rapidly growing number of targeted cancer therapeutic drugs that are under development. With approximately 600-700 targeted drugs in the drug development pipeline, oncologists will need new diagnostic tools to manage and predict appropriate combination drug therapies. While doctors treating HIV patients have tests to help them manage HIV combination therapies, similar systems for cancer patients are in their infancy.
|
