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Tagrisso Gains FDA Approval for Treatment of Unresectable Stage III EGFR-Mutated Lung Cancer in the US

NextEdge Admin

27 Sep 2024

2 min 55 sec

AstraZeneca's Tagrisso (osimertinib) has been approved by the US FDA for the treatment of adult patients with unresectable, Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) who have not experienced disease progression during or after platinum-based chemoradiation therapy (CRT). This approval was based on results from the Phase III LAURA trial, which were presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and published in *The New England Journal of Medicine*.

In the LAURA trial, Tagrisso demonstrated a significant 84% reduction in the risk of disease progression or death compared to placebo (hazard ratio 0.16; 95% confidence interval 0.10-0.24; p<0.001). Median progression-free survival (PFS) was 39.1 months in the Tagrisso group versus just 5.6 months in the placebo group. Although overall survival (OS) data remains immature, it is being further evaluated as a secondary endpoint in the ongoing trial.

Approximately 15% of NSCLC patients in the US have EGFR mutations, and nearly one in five NSCLC cases involves unresectable tumors. Dr. Suresh Ramalingam, Executive Director of Winship Cancer Institute and principal investigator of the LAURA trial, described the approval as a major breakthrough for patients with Stage III, EGFR-mutated lung cancer. He emphasized that osimertinib allowed patients to live without disease progression for more than three years, underscoring the importance of early testing and diagnosis.

Dave Fredrickson, AstraZeneca's Executive Vice President of the Oncology Business Unit, highlighted the significance of this approval for EGFR-mutated NSCLC patients, providing them with a new targeted therapy option. The safety profile of Tagrisso in the LAURA trial remained consistent with previous studies, with no new safety concerns identified. Tagrisso is already approved for several EGFR mutation-related indications and is currently under regulatory review in other countries for this expanded use.