Posted by Michael Wonder on 18 Dec 2017
US FDA accepts regulatory submission for Tagrisso in first-line EGFR-mutated non-small cell lung cancer
18 December 2017 - Tagrisso granted priority review.
AstraZeneca today announced that the US FDA has accepted a supplemental bew drug application for the use of Tagrisso (osimertinib), a third-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) with clinical activity against central nervous system metastases, in the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have EGFR mutations (exon 19 deletions or exon 21 (L858R) substitution mutations).
The FDA has granted Tagrisso Priority Review status and previously granted Breakthrough Therapy Designation in the first-line treatment of patients with metastatic EGFR mutation-positive (EGFRm) NSCLC.
The submission acceptance is based on data from the Phase III FLAURA trial, in which Tagrisso significantly improved progression-free survival compared to current 1st-line EGFR-TKIs, erlotinib or gefitinib, in previously-untreated patients with locally-advanced or metastatic EGFRm NSCLC.
