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Related Topics >> EMEA Approval | Iressa | AstraZeneca

AZ wins European approval for Iressa

It's been a long time coming, but AstraZeneca says that the European Commission has approved its oral cancer drug Iressa. AZ withdrew its EU app in 2005 and resubmitted it in early 2008. In a sign of the growing importance of personalized therapies, the approval is for adults with locally advanced or metastatic non-small cell lung cancer whose tumors have an EGFR mutation. The drug scrambles cellular communications required for tumor growth. Once seen as a potential blockbuster, Iressa stumbled badly when a late-stage trial failed to demonstrate positive results in 2004. Now, though, the therapy could start a comeback. Report

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