Amgen asks FDA to narrow Vectibix use

To hear the experts tell it, the future of personalized medicine hangs in the balance today. An FDA advisory panel is set to talk over standards for linking genetic tests with cancer drugs. How should patients most likely to benefit be identified? What if a drug is approved for general use, but then scientists discover that it works best--or only works--in patients with specific genetic features?

Take, for instance, Erbitux, Forbes suggests. Or Amgen's Vectibix. Both drugs were approved for advanced colon cancer patients who failed other treatments, but this year researchers discovered that the drugs are ineffective for patients with a KRAS gene mutation. Now, in a complete turnabout from usual pharma procedure, Amgen is asking the FDA to narrow the use of Vectibix for only those patients who don't carry that KRAS mutation. "I don't believe that any patient with mutant kras should be receiving Vectibix," R&D chief Roger Perlmutter told the magazine. And Lilly's ImClone Systems wants Erbitux's label updated with gene test info.

The FDA, however, has been reluctant to restrict the drugs. That could change today. One analyst wrote to investors that there's a good chance the advisory committee will link the drugs to genetic testing. The KRAS evidence is quite strong. But other drugs and other genetic variations could get very complicated. Stay tuned to hear what the experts decide.

- read the Forbes story
- see the release from Amgen

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