Posted by Michael Wonder on 13 Jul 2018
Health Canada approves Tagrisso (osimertinib) as first-line treatment for EGFR-mutated non-small cell lung cancer
12 July 2018 - Pivotal FLAURA study demonstrated 18.9 months median progression-free survival for patients receiving Tagrisso versus 10.2 months compared with earlier generation EGFR tyrosine kinase inhibitors.
AstraZeneca Canada today announced that Health Canada has approved Tagrisso (osimertinib) for the first-line treatment of patients with locally advanced (not amenable to curative therapies), or metastatic non-small cell lung cancer whose tumours have epidermal growth receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations (either alone or in combination with other EGFR mutations).
Tagrisso has been granted a Notice of Compliance under priority review status based on data from the phase III FLAURA trial, which showed that patients who received first-line treatment of Tagrisso demonstrated 18.9 months median progression-free survival (PFS) versus 10.2 months in patients receiving earlier generation first-line EGFR tyrosine kinase inhibitors (TKI) erlotinib or gefitinib. In addition, preliminary overall survival (OS) data from the study indicated a 37 per cent reduction in the risk of death (hazard ratio 0.63 at 25% maturity, not statistically significant as the OS data is still immature).
