The US Food and Drug Administration has issued new guidelines in a bid to speed up the development of “personalised medicines” through the field of science known as pharmacogenomics.
The FDA first launched its pharmacogenomic initiative back in November 2003 [[04/11/03f]], and clearly believes that such research could be a Holy Grail for drug development. Understanding why certain people react differently to the same drugs could ultimately lead to individualised therapy by predicting who has a greater chance of benefiting from a given therapy, as well as tracking down the cause of certain rare, serious drug side effects.
The FDA’s final guidance clarifies how pharmacogenomic data will be evaluated and describes what data will be needed during the marketing application review process, and how the information will be used during the decision-making. The guidance also outlines how firms can voluntarily submit research data. Although these voluntary data will not be used for regulatory purposes, the FDA says they will help both the agency and the pharmaceutical industry as the field continues to evolve. The FDA believes this approach will save time and resources and eliminate possible delays in the review process because parties will be able to familiarise themselves with pharmacogenomic approaches as they evolve.
Some FDA-approved drugs already apply the technology. For example, genomic tests are helping to identify cancers that have a good chance of responding to a particular medication or regimen, which has helped in the development of targeted therapies, such as Roche’s breast cancer drug, Herceptin (trastuzumab), Novartis’ Gleevec (imatinib) for chronic myeloid leukemia and ImClone Systems’ colorectal cancer drug, Erbitux (cetuximab). The FDA also recently approved the first laboratory test – Roche’s Amplichip Cytochrome P450 Genotyping Test – which will enable physicians to use genetic information to select the right doses of certain medications for cardiac, psychiatric diseases and cancer.
“This new technology will allow medicines to be uniquely crafted to maximise their therapeutic benefits and minimise their potential risks for each patient,” explained Janet Woodcock, acting deputy commissioner for operations at the FDA.