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AstraZeneca's Nuanced View of Drug Development

Executive Summary

With its small-molecule signal transduction inhibitor Iressa, the first approved drug targeting the EGF receptor, AstraZeneca became an early mover in the development of molecularly targeted cancer drugs. But Iressa also became the poster child for the difficulties associated with targeted therapies when a Phase III trial failed soon after the drug was approved. Iressa's ups-and-downs have brought home the need for "guided empiricism" to link targets in the clinic to markers and dosing. Yet even as AstraZeneca and others make connections linking target biology to disease propensity or status, clinical drug development continues. And if history is a guide, industry should expect more Iressa-type missteps.

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