FDA Verdict Could Determine Future Of Personalized Medicine

Pharmaceutical giants Amgen, Bristol-Myers Squibb, and Eli Lilly have asked the Food and Drug Administration (FDA) to require that patients take a genetic test before receiving their anti-cancer drugs.

The move is designed to identify those patients whose cancers are most likely to respond to a particular drug, speeding the course of treatment and reducing potentially harmful side effects. Recent genetic studies have shown that certain classes of drugs are completely ineffective in patients whose cancers are of a particular genetic subtype. It's also well-known that individuals metabolize drugs differently, based on their genetic makeup.

For example, in 2007 the FDA approved a genetic test for patients taking warfarin, an anti-clotting drug. Dangerous side effects can occur in patients whose genes limit their ability to metabolize the drug. The FDA also recently approved a genetic test to determine which patients are good candidates for the anti-breast cancer drug Herceptin.

For more on this topic, see Dr. Rex Chisholm's feature article on personalized medicine.