FDA approves osimertinib plus chemo as first-line treatment for EGFR-mutated lung cancer, improving survival.

On February 16, the U.S. Food and Drug Administration (FDA) approved osimertinib (Tagrisso) with platinum-based chemotherapy for patients with locally advanced or metastatic non–small cell lung cancer (NSCLC) whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test.


Efficacy was evaluated in FLAURA2 ( identifier NCT04035486), an open-label, randomized trial of 557 patients with EGFR exon 19 deletion or exon 21 L858R mutation–positive locally advanced or metastatic NSCLC and no prior systemic therapy for advanced disease. Patients were randomly assigned 1:1 to receive either osimertinib with platinum-based chemotherapy or osimertinib monotherapy.

The major efficacy outcome measure was investigator-assessed progression-free survival, with overall survival as a key secondary outcome measure. Osimertinib plus platinum-based chemotherapy demonstrated a statistically significant improvement in progression-free survival compared to osimertinib monotherapy, with a hazard ratio of 0.62 (95% confidence interval [CI] = 0.49–0.79, two-sided P < .0001). Median progression-free survival was 25.5 months (95% CI = 24.7 months to not estimable) and 16.7 months (95% CI = 14.1–21.3 months) in the respective arms.

While overall survival results were immature at the time of the current analysis, with 45% of prespecified deaths for the final analysis reported, no trend toward a detriment was observed.

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