AZ submits NDA to Japan’s authorities for Tagrisso

AstraZeneca on Monday announced the submission of a supplemental new drug application (sNDA) to Japan’s Pharmaceuticals and Medical Devices Agency for the use of Tagrisso(osimertinib).

That is a third-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) with clinical activity against central nervous system (CNS) metastases, for the 1st-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 Tagrissosignificantly 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.

Image: FILE PHOTO: The logo of AstraZeneca is seen on a medication package at a pharmacy in London April 28, 2014. To match Insight CHINA-CANCER/BLACK MARKET REUTERS/Stefan Wermuth/File Photo

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