Cancer is the uncontrollable multiplication of cells. It is a word that covers approximately 110 distinct ailments.
To accelerate the war on cancer, new targeted gene-based drug therapies require targeted diagnostics (the ability to define a disease state). Recent FDA rejections of multiple drugs due to their failure to impact a large portion of their intended patient population shows how slowly the pharmaceutical industry and the FDA is adapting to recent advances in the biosciences. Two targeted gene-therapeis that have passed the FDA, Genetech's Herceptin for breast cancer or Novartis' Gleevec for leukemia, have done so by selecting a small subset of the patient population that exhibit the characteristic gene or protein that their targeted therapy was designed attack. On the same day the FDA approved Herceptin they also approved Dako's HercepTest which is a standardized diagnostic test that shows whether the patient has the specific form of cancer that Herceptin can help. Specific diagnostics are exactly what will be required in the new gene-based therapeutic era.
Seems simple enough, but fighting cancer is quite complex. At least 200 defective genes play a role in causing cancer, and in any one patient probably only 5 or 6 of the 200 genes are involved, while in the next patient a different mix of genes is at work. Acclerating this process will require that the FDA issue new guidelines on how to target new treatments at the smaller circle of patients; the development of standarized test to determine which particular genetic flaws lie behind an individual patient's cancer; and the sharing and biosimulation of genomic, proteomic information across the research and industry groups. This will not be an easy task in such a highly competitive industry.
It is still 20-25 years away before we eliminate cancer. Make no mistake, targeted therapies and cellular reregulation will work. More on how we will eliminate cancer later.
10:46:26 AM comment