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AstraZeneca's Tagrisso gets US FDA priority review in 1st-line lung cancer

The U.S. Food and Drug Administration accepted and granted priority review to AstraZeneca PLC's supplemental new drug application for Tagrisso as a first-line treatment of patients with metastatic non-small cell lung cancer, or NSCLC.

The submission was based on data from the phase 3 Flaura trial under which Tagrisso significantly improved progression-free survival compared to Tarceva or Iressa in previously untreated patients with locally advanced or metastatic NSCLC whose tumors have epidermal growth factor receptor, or EGFR, mutations.

The FDA granted breakthrough therapy designation to Tagrisso in October for the said indication.

Tarceva, or erlotinib, is developed and sold by Astellas Pharma Inc. in partnership with Roche Holding AG's Genentech Inc. in the U.S. Iressa, or gefitinib, is sold by AstraZeneca.