Source - SMW
The US Food and Drug Administration has accepted AstraZeneca's regulatory submission for Tagrisso for the treatment of patients with metastatic non-small cell lung cancer.

 AstraZeneca said the FDA had accepted a supplemental new 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 (CNS) 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.  

 AstraZeneca said the  submission acceptance was based on data from the Phase III FLAURA trial, in which Tagrisso significantly improved progression-free survival (PFS) compared to current first-line EGFR-TKIs, erlotinib or gefitinib, in previously-untreated patients with locally-advanced or metastatic EGFRm NSCLC.