AstraZeneca announced that the Food and Drug Administration (FDA) has approved Tagrisso (osimertinib) as first-line treatment for patients with epidermal growth factor receptor (EGFR)-mutated (exon 19 deletions or exon 21 L858R mutations) metastatic non-small cell lung cancer (NSCLC), as detected by an FDA-approved test. 

The approval was supported by results from the Phase 3 FLAURA trial (N=556) which compared Tagrisso 80mg daily to erlotinib 150mg daily or geftinib 250mg daily — current first-line EGFR tyrosine kinase therapies — among patients with locally advanced or metastatic EGFR-mutated NSCLC. 

Results showed that progression-free survival (PFS), the primary endpoint, was significantly longer in Tagrisso-treated patients vs EGFR tyrosine kinase inhibitor-treated patients (18.9 months vs 10.2 months; hazard ratio [HR] 0.46, 95% CI: 0.37, 0.57; P <.0001). The effect on PFS was consistent across all pre-specified patient subgroups, including patients with or without central nervous system (CNS) metastases.

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Compared to geftinib or erlotinib therapy, objective response rate (ORR) was higher among Tagrisso-treated patients (69% vs 77%) with a greater proportion of patients achieving complete (1% vs 2%) and partial (68% vs 75%) responses. Moreover, the median duration of response was 17.6 months in the Tagrisso group vs 9.6 months in the EGFR tyrosine kinase inhibitors group. At the time of final PFS analysis, overall survival data were not yet mature. The safety profile of Tagrisso in the FLAURA trial was consistent with what was seen in previous trials.

Tagrisso, a third-generation EGFR tyrosine kinase inhibitor, is already approved for the treatment of patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR TK1 therapy. It is available in 40mg and 80mg strength tablets. 

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