AZ submits Tagrisso application in Japan



AstraZeneca has submitted a supplemental new drug application for its lung cancer drug Tagrisso to Japan’s Pharmaceuticals and Medical Devices Agency. AstraZenecahas submitted the sNDA 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, for the first-line treatment of patients with inoperable or recurrent EGFR mutation-positive (EGFRm) non-small cell lung cancer (NSCLC). The Japan sNDA is based on data from the phase III FLAURA trial, in which Tagrisso significantly improved progression-free survival (PFS) compared to current 1st-line EGFR-TKIs, erlotinib or gefitinib, in previously-untreated patients with locally-advanced or metastatic EGFRm NSCLC. Story provided by