UK pharmaceutical major AstraZeneca (AZ, NASDAQ: AZN) has announced that the European Commission (EU) has granted another indication approval for its drug Tagrisso (osimertinib). The approval is for the treatment of adult patients with locally advanced, unresectable non-small cell lung cancer (NSCLC) whose tumors exhibit epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations and have not progressed during or following platinum-based chemoradiation therapy (CRT).
Tagrisso’s Global Approval Status and EU Nod Based on LAURA Study
Tagrisso, a third-generation, irreversible EGFR tyrosine kinase inhibitor (EGFR-TKI), is already approved in many regions globally for multiple EGFR mutant NSCLC indications. The EU’s decision to approve Tagrisso is based on the positive results from the Phase III LAURA study. In this study, Tagrisso demonstrated a significant reduction in the risk of disease progression or death by 84% compared to placebo, with a hazard ratio of 0.16 (95% confidence interval 0.10-0.24; p<0.001). The median progression-free survival (PFS) was considerably longer at 39.1 months for patients treated with Tagrisso, compared to 5.6 months for the placebo group. While overall survival (OS) results are still immature, they will continue to be assessed as a secondary endpoint in the study.-Fineline Info & Tech
