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# FDA Accepts Tagrisso sNDA, Grants Priority Review
- URL: https://www.fdaweb.com/fda-accepts-tagrisso-snda-grants-priority-review/
- Published: 2020-10-20T12:00:00.000Z
- Updated: 2026-09-14T16:33:15.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147913

FDA has accepted an AstraZeneca sNDA for Tagrisso (osimertinib) and will give it priority review for adjuvant treatment of patients with early-stage epidermal growth factor receptor-mutated non-small cell lung cancer after complete tumor resection with curative intent. A company [statement](https://www.astrazeneca.com/media-centre/press-releases/2020/tagrisso-adjuvant-lung-cancer-us-priority-review.html?ref=fdaweb.com) says the sNDA was based on results from the ADAURA Phase 3 trial showing Tagrisso demonstrated a statistically significant and clinically meaningful improvement in disease-free survival in the primary analysis population of patients with Stage 2 and 3A epidermal growth factor receptor-mutated non-small cell lung cancer, and also in the overall trial population of patients with Stage 1B-3A disease.

Earlier this year, an independent data monitoring committee recommended that the trial be unblinded two years early based on a determination of overwhelming efficacy. Investigators and patients continue to participate in the trial and remain blinded to treatment, AZ says.

Tagrisso received a breakthrough therapy designation 7/2020\. It is approved for both the first-line treatment of patients with locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer and for the treatment of locally advanced or metastatic epidermal growth factor receptor T790M mutation-positive non-small cell lung cancer in the U.S. and several other countries.