The US Food and Drug Administration (FDA) has approved AstraZeneca's Tagrisso (osimertinib)​ to treat adults with unresectable stage III EGFR-mutated non-small cell lung cancer (NSCLC).

The decision is specifically for those whose disease has not advanced during or after platinum-based chemoradiation therapy.

Tagrisso, which targets exon 19 deletions or exon 21 (L858R) mutations, received the approval following a priority review.

The FDA's decision was based on the results from the LAURA Phase III trial.

Tagrisso demonstrated an 84% reduction in the risk of disease progression or death when compared to a placebo.

This was determined through an assessment by a blind independent central review (hazard ratio 0.16; 95% confidence interval 0.10-0.24; p<0.001). Median progression-free survival for patients treated with Tagrisso was 39.1 months, significantly longer than the 5.6 months observed for those on placebo.

While the overall survival (OS) results are still considered immature at this stage of analysis, the study continues to evaluate OS as a secondary endpoint.

AstraZeneca oncology business unit executive vice-president Dave Fredrickson said: “The approval of Tagrissofor patients with stage III, unresectable EGFR-mutated non-small cell lung cancer addresses a critical need for patients with these mutations who have never had the option of targeted therapy before.

“The results of the LAURA trial show the powerful impact Tagrisso can make as backbone therapy in this disease, and with this approval, patients across all stages of EGFR-mutated non-small cell lung cancer can now benefit.”

Tagrisso is not only approved for this new indication but also for the first-line metastatic setting as a single agent, in combination with chemotherapy, and as an adjuvant early-stage disease treatment.

It is undergoing review by regulatory authorities in countries worldwide for the same indication.