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# AstraZeneca’s Tagrisso OK’d for First-line Lung Cancer
- URL: https://www.fdaweb.com/astrazenecas-tagrisso-okd-for-first-line-lung-cancer/
- Published: 2018-04-19T12:00:00.000Z
- Updated: 2026-09-14T23:59:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141264

FDA has expanded approval for AstraZeneca’s Tagrisso (osimertinib) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) mutations (exon 19 deletions or exon 21 L858R mutations), as detected by an FDA-approved test. Approval was based on data from the Phase 3 FLAURA trial where Tagrisso demonstrated a median progression-free survival of 18.9 months vs 10.2 months for EGFR tyrosine kinase inhibitor comparators erlotinib or gefitinib. Tagrisso is already approved for the second-line treatment of patients with metastatic EGFR-mutated NSCLC, whose disease has progressed on or after a first-line therapy and who have developed the secondary T790M mutation, as detected by an FDA-approved test.