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Amendment: Tagrisso significantly improves overall
Amendment: Tagrisso significantly improves overall.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \nRNS Number : 5517I AstraZeneca PLC 09 August 2019 \n\n \n \nThe following amendment(s) has (have) been made to the 'Tagrisso significantly improves overall survival in the Phase III FLAURA trial for 1st-line EGFR-mutated non-small cell lung cancer' \n announcement released on 09 August 2019 at 07:00 BST under RNS No 5270I.\n \nCorrection: Tagrisso 40mg and 80mg once-daily oral tablets are not approved in China for 1st-line EGFRm advanced NSCLC. Tagrisso has received approval in more than 70 countries, including the US, Japan and the EU, for 1st-line EGFRm advanced NSCLC, and in more than 80 countries, including the US, Japan, China and the EU, for 2nd-line use in patients with EGFR T790M mutation-positive advanced NSCLC. \n \nAll other details remain unchanged.\n \nThe full amended text is shown below.\n \n \n9 August 2019 07:00 BST\n \nTagrisso significantly improves overall survival in the Phase III FLAURA trial for 1st-line EGFR-mutated non-small cell lung cancer \n \nTagrisso is the only medicine demonstrating statistically-significant overall survival benefit in this setting. Also increased the time patients with central nervous\n system metastases lived without disease progression\n \nAstraZeneca today announced positive overall survival (OS) results from the Phase III FLAURA trial, a randomised, double-blinded, multi-centre trial of Tagrisso (osimertinib) in previously-untreated patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) mutations.\n \nTagrisso showed a statistically-significant and clinically-meaningful improvement in OS, a secondary endpoint in the FLAURA Phase III trial, compared with erlotinib or gefitinib both of which were previous standard-of-care (SoC) treatments in this setting. The FLAURA trial met its primary endpoint in July 2017, showing a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS), increasing the time patients lived without disease progression or death from any cause. The safety and tolerability of Tagrisso was consistent with its established profile.\n \nJosé Baselga, Executive Vice President, Oncology R&D said: \"Today's positive results show that Tagrisso provide...