AstraZeneca announced Thursday that a committee of the European Medicines Agency recommended approval for Iressa (gefitinib) in adults with locally advanced or metastatic non-small-cell lung cancer (NSCLC) with activating mutations of EGFR-TK.

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The positive opinion stipulates, however, that the drugmaker must conduct a study to generate further data in a Caucasian population of patients with NSCLC. The drugmaker said it is in talks with the Committee for Medicinal Products for Human Use to finalise the design and endpoints of the trial.

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