AstraZeneca PLC (LON:AZN) has submitted a supplemental new drug application in Japan for lung cancer treatment Tagrisso.
Following positive phase III trial results, the company has sent its request to Japan's Pharmaceuticals and Medical Devices Agency for the use of Tagrisso for first-line treatment of patients with inoperable or recurrent epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC).
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The phase III Flaura trial showed Tagrisso significantly improved progression-free survival compared to treatments erlotinib or gefitinib in previously untreated patients with locally-advanced or metastatic EGFR mutation-positive NSCLC.
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Tagrisso 40mg and 80mg once-daily oral tablets have been approved in more than 60 countries, including the US, the European Union, Japan and China for patients with EGFR T790M mutation-positive advanced NSCLC.