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AstraZeneca's Iressa Problem

In May of this year, two major scientific journals published papers correlating response to Iressa, AstraZeneca's targeted therapy for refractory non-small cell lung cancer, to a series of mutations clustered in a section of the EGFR gene. These widely publicized findings are fueling discussions that are bound to have consequences not only for AstraZeneca, patients and clinicians, but also for many pharmaceutical companies working on targeted therapies.

The effort to find and apply medically relevant biomarkers got a kick-start in Spring 2003 when The Boston Globe profiled the remarkable story of a Mrs. R, a 45-year-old nurse and mother who had been diagnosed in November 2002 with a fast-acting fatal form of lung cancer. Six months after diagnosis, following treatment with AstraZeneca PLC 's gefitinib (Iressa), she was not only surviving but in complete remission and living a nearly normal life.

Daniel Haber, MD, PhD, director of the Massachusetts General Hospital Cancer Center and chairman of the cancer genetics program at the Dana-Farber/ Harvard Cancer Center, read the article and immediately...

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