Personalized medicine

FDA Consumer, July-August, 2005

As part of an initiative to speed the development of new products through the science of pharmacogenomics, the FDA has issued a final guidance for industry titled Pharmacogenomic Data Submissions.

Through pharmacogenomics, health care providers can evaluate an individual's genetic profile and predict the best possible drug therapy and dose. For example, genomic tests are helping to identify cancers that have a good chance of responding to a particular medication or regimen. This technology has enabled the development of targeted therapies like Herceptin for metastatic breast cancer, Gleevec for chronic myeloid leukemia, and Erbitux for metastatic colorectal cancer.

"FDA's efforts will bring us one step closer to 'personalizing' medical treatment," says Janet Woodcock, M.D., acting deputy commissioner for operations at the FDA. "This new technology will allow medicines to be uniquely crafted to maximize their therapeutic benefits and minimize their potential risks for each patient."

The FDA also recently approved the AmpliChip Cytochrome P450 Genotyping Test. It's the first laboratory test that allows physicians to use genetic information to select the right doses of certain medications for cardiac treatment, psychiatric diseases, and cancer.

Visit www.fda.gov/cder/genomics/default.htm for more information on pharmacogenomics.