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By Gina Shaw
When the FDA approved osimertinib (Tagrisso, AstraZeneca) in November 2015 for patients with non-small cell lung cancer (NSCLC) whose tumors have the epidermal growth factor receptor (EGFR) T790M mutation and have been resistant to other EGFR inhibitors, it was under the agency’s accelerated approval process, which mandated confirmatory trials.
On July 18, AstraZeneca issued top-line results from its AURA3 Phase III trial, stating that osimertinib had