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# FDA Gives ‘Breakthrough’ Status for AstraZeneca’s Tagrisso
- URL: https://www.fdaweb.com/fda-gives-breakthrough-status-for-astrazenecas-tagrisso/
- Published: 2017-10-09T12:00:00.000Z
- Updated: 2026-09-14T22:54:58.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139813

FDA has granted AstraZeneca a breakthrough therapy designation for Tagrisso (osimertinib) for the first-line treatment of patients with metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC). The designation was based on data from the Phase 3 FLAURA trial of Tagrisso versus standard-of-care EGFR tyrosine kinase inhibitor (TKI) therapy in previously-untreated patients with locally-advanced or metastatic EGFR mutation-positive NSCLC. In the trial, according to the company, “median progression-free survival was nearly double at 18.9 months for Tagrisso compared with 10.2 months for current first-line EGFR TKIs (erlotinib or gefitinib). Improvements were seen in all pre-specified subgroups, including patients with and without brain metastases.” This is the sixth breakthrough designation that AstraZeneca has received for an oncology medicine since 2014.

Tagrisso is a third-generation, irreversible EGFR TKI designed to inhibit both EGFR-sensitizing and EGFR T790M-resistance mutations, with clinical activity against central nervous system metastases, AstraZeneca says. It is currently approved for patients with EGFR T790M mutation-positive advanced NSCLC.