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FDA approves new indication for Tagrisso

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Approval was based on results from the ADAURA phase three trial in which adjuvant treatment with Tagrisso reduced the risk of disease recurrence or death by 83 percent in the primary endpoint of DFS in patients with stage II and IIIA disease (hazard ratio=0.17; 95 percent confidence interval, 0.12­–0.23; p<0.0001). DFS results in the overall trial population of patients with stage IB-IIIA disease showed Tagrisso reduced the risk of disease recurrence or death by 80 percent (HR=0.20; 95 percent CI, 0.15-0.27; p<0.0001). At two years, 89 percent of patients treated with Tagrisso remained alive and disease free versus 52 percent on placebo after surgery.

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