Posted by Michael Wonder on 28 Nov 2017
The European Medicines Agency accepts regulatory submission for Tagrisso in first-line EGFR-mutated non-small cell lung cancer
28 November 2017 - Acceptance is based on positive Phase III FLAURA trial results.
AstraZeneca today announced that the EMA has accepted a variation to the marketing authorisation application for Tagrisso (osimertinib), a third-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) with clinical activity against central nervous system (CNS) metastases, for the first-line treatment of adult patients with locally-advanced or metastatic non-small-cell lung cancer (NSCLC) whose tumours have EGFR mutations (exon 19 deletions or exon 21 (L858R) substitution mutations).
The submission is based on data from the Phase III FLAURA trial, in which Tagrisso 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.
