AZ's Tagrisso under review in EU for first-line advanced NSCLC

AstraZeneca plc (LSE:AZN; NYSE:AZN) said EMA accepted for review a variation to the MAA for Tagrisso osimertinib (AZD9291) as a first-line treatment in adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have EGFR mutations, which include exon 19 deletions or exon 21 (L858R) substitution mutations.

The application is based on data from the Phase III FLAURA trial in treatment-naïve patients with locally advanced or metastatic EGFR-mutant NSCLC that showed the drug met the primary endpoint of improving progression-free survival (PFS) vs. standard of care (SOC) with Tarceva erlotinib or Iressa gefitinib (18.9 months vs. 10.2 months, HR=0.46, 95% CI: 0.37, 0.57, p<0.0001) (see BioCentury, Sept. 14)...