AstraZeneca (LON: AZN) has submitted a supplemental new drug application (sNDA) to Japan's Pharmaceuticals and Medical Devices Agency for Tagrisso (osimertinib) as a first-line treatment for patients with inoperable or recurrent epidermal growth factor receptor mutation-positive (EGFRm) non-small cell lung cancer (NSCLC), the company announced on Monday.

Tagrisso is a third-generation, irreversible EGFR tyrosine kinase inhibitor (TKI) that is designed to inhibit both EGFR-sensitising and EGFR T790M-resistance mutations, with clinical activity against central nervous system (CNS) metastases.

The submission is based on data from AstraZeneca's Phase III FLAURA trial. The double-blind, randomised trial involved 556 patients and was conducted across 29 countries.

The aim of the trial was to assess the safety and efficacy of Tagrisso 80mg given once daily vs standard-of-care EGFR-TKIs (either erlotinib 150mg given orally, once daily, or gefitinib 250mg given orally, once daily).

Results from the trial revealed that Tagrisso significantly improved progression-free survival (PFS) when compared to current first-line treatments, when given to previously-untreated patients with locally-advanced or metastatic EGFRm NSCLC.