United Kingdom-based AstraZeneca has submitted a supplemental new drug application to Japan's pharmaceuticals and medical devices agency seeking approval for Tagrisso (osimertinib), it was reported yesterday.

The product is intended as a first line treatment for patients with inoperable or recurrent EGFR mutation-positive (EGFRm) non-small cell lung cancer (NSCLC). The product is a third-generation and irreversible epidermal growth factor receptor tyrosine kinase inhibitor with clinical activity against central nervous system metastases. It is designed to inhibit both EGFR-sensitising and EGFR T790M-resistance mutations.

The firm has submitted supplemental new drug application based on data from the phase III Flaura trial, in which the product significantly improved progression-free survival compared with first-line EGFR-TKIs, erlotinib or gefitinib, in earlier-untreated patients with locally-advanced or metastatic EGFRm non-small cell lung cancer. It is also being studied in the adjuvant setting and in combination with other treatments.