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In July, the European Commission approved the marketing of gefitinib (Iressa) for selected patients with non-small cell lung cancer, a milestone for a drug whose ups and downs have reflected the sometimes difficult road toward personalized medicine in oncology.

The key ingredient in the commission's approval is patient selection–the proviso that gefitinib be used only in patients with certain mutations in the epidermal growth factor receptor (EGFR) gene that make them sensitive to the drug. AstraZeneca, the drug's maker, is in discussions with the U.S. Food and Drug Administration as well, according to a company spokesperson.

Although EGFR-targeted therapies for lung cancer–gefitinib and its cousin erlotinib (Tarceva)–have been available for some time, they have been tested in all patients, with no selection, said Roy Herbst, M.D., Ph.D., chief of thoracic medical oncology at the University of Texas M.D. Anderson Cancer Center in Houston. And that isn’t really what personalized medicine is about, he said.

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