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# Priority Review for Tagrisso sNDA in Lung Cancer
- URL: https://www.fdaweb.com/priority-review-for-tagrisso-snda-in-lung-cancer/
- Published: 2023-10-16T12:00:00.000Z
- Updated: 2026-09-14T19:02:37.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155571

FDA has accepted for priority review an AstraZeneca supplemental NDA for Tagrisso (osimertinib) in combination with chemotherapy for treating adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC). The agency has set a user fee review action target date of the first quarter of 2024.

The submission is based on data from the company’s FLAURA2 Phase 3 trial which showed Tagrisso plus chemotherapy extended median progression-free survival by nearly nine months compared to Tagrisso alone for patients with locally advanced (Stage 3B-3C) or metastatic (Stage 4) EGFRm NSCLC. Results showed Tagrisso plus chemotherapy reduced the risk of disease progression or death by 38% compared to Tagrisso alone, the company says.

The drug was approved in 2015 for patients whose tumors with EGFR mutation (T790M) and whose disease has progressed after treatment with other EGFR-blocking therapies. In 2018, expanded approval was granted for the first-line treatment of growth factor receptor EGFR mutations exon 19 deletions or exon 21 L858R.

AstraZeneca notes that it has several ongoing Tagrisso Phase 3 trials focused on earlier stages of lung cancer, including a trial in the Stage 1A2-1A3 adjuvant resectable setting (ADAURA2), and in the Stage 3 locally advanced unresectable setting (LAURA). It is also studying ways to address tumor mechanisms of resistance through the SAVANNAH and ORCHARD Phase 2 trials, and the SAFFRON Phase 3 trial.