United Kingdom-based AstraZeneca has received approval from the US Food and Drug Administration (FDA) for its Tagrisso (osimertinib) as the first-line treatment for patients with metastatic non-small cell lung cancer whose tumours have epidermal growth factor receptor mutations, it was reported yesterday.

The approval is based on results from the Phase III FLAURA trial, which were revealed at the European Society of Medical Oncology 2017 Congress. The FLAURA trial compared Tagrisso to current 1st-line EGFR tyrosine kinase inhibitors (TKIs), erlotinib or gefitinib, in earlier-untreated patients with locally-advanced or metastatic EGFR-mutated (EGFRm) non-small cell lung cancer.

The product met the primary endpoint of progression-free survival. Progression-Free Survival results with Tagrisso were consistent across all pre-specified patient subgroups, including in patients with or without central nervous system metastases. Overall survival data were not mature at the time of the final Progression-Free Survival analysis. Safety data for the product in the FLAURA trial were in line with those observed in prior clinical trials.