European regulators are reviewing AstraZeneca’s application to market Tagrisso for the first-line treatment of adults with locally-advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours have EGFR mutations.

The submission is based on data from the Phase III FLAURA trial, which showed that the third-line epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) significantly improved progression-free survival (PFS) compared to current 1st-line EGFR-TKIs, erlotinib or gefitinib, in previously-untreated patients with locally-advanced or metastatic EGFRm NSCLC.

According to the data, progression free survival in patients taking Tagrisso was 18.9 months compared to 10.2 months for those receiving the standard of care, while the objective response rate was 80 percent versus 76 percent, respectively.

“The FLAURA data are truly exciting,” said AZ’ chief medical officer commenting on the results back in September.

“Until now, even with the therapeutic advances offered by the first- and second-generation EGFR inhibitors, less than 20 percent of EGFR mutation-positive NSCLC patients survive for five years.

“The FLAURA data suggest early and sustained benefit with Tagrisso that has the potential to significantly impact long-term patient outcomes and help address the considerable unmet need that remains.”

Tagrisso is currently approved in several countries around the globe as a second-line treatment for patients with EGFR T790M mutation-positive advanced NSCLC.