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news.AstraZeneca has agreed to limit access to its lung cancer drug Iressa after the FDA concluded that clinical testing had been unable to prove the treatment's survival benefit.
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Based on the FDA’s assessment of currently data and the availability of other treatment options in the US that do prolong life, AstraZeneca said that it would revise Iressa’s label to restrict the drug’s use to patients who have previously taken and benefited from the therapy.
Iressa originally received accelerated approval from the FDA in 2003 despite limited proof of the drug’s efficacy. The drug was then found to be unable to significantly extend the lives of patients with non-small-cell lung cancer in a pivotal study completed last year.
AstraZeneca said that it would continue to evaluate potential predictive biomarkers to better identify more readily those patients who are most likely to benefit from Iressa.