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Tagrisso approved in China in early lung cancer
Tagrisso approved in China in early lung cancer.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n \n \n \n RNS Number : 4182V\n AstraZeneca PLC\n 14 April 2021\n \n \n \n 14 April 2021 07:00 BST\n \n \n \n Tagrisso\n \n \n approved in China for the adjuvant treatment\n \n \n \n of\n \n \n patients with early-stage EGFR-mutated lung cancer\n \n \n \n \n \n \n Tagrisso is the only targeted medicine to show efficacy in the treatment of early-stage lung cancer in a global trial and the first such medicine approved in China\n \n \n \n \n Approval based on unprecedented results from the ADAURA Phase III trial\n \n where Tagrisso reduced the risk of disease recurrence or death by 80%\n \n \n \n \n AstraZeneca's Tagrisso (osimertinib) has been approved in China for the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after tumour resection with curative intent, with or without adjuvant chemotherapy as recommended by the patient's physician. Tagrisso is indicated for EGFRm patients whose tumours have exon 19 deletions or exon 21 (L858R) mutations.\n \n \n The approval by China's National Medical Products Administration (NMPA) was based on positive results from the ADAURA Phase III trial. In the trial, Tagrisso demonstrated a statistically significant and clinically meaningful improvement in disease-free survival (DFS) in the primary analysis population of patients with Stage II and IIIA EGFRm NSCLC. The ADAURA trial also showed a statistically significant and clinically meaningful improvement in DFS in the overall trial population of patients with Stage IB-IIIA disease, a key secondary endpoint.\n \n While up to 30% of all patients with NSCLC may be diagnosed early enough to have surgery with curative intent, recurrence is still common in early-stage disease. Historically, nearly half of patients diagnosed in Stage IB, and over three quarters of patients diagnosed in Stage IIIA, have experienced recurrence within five years.1-3 More than a third of the world's lung cancer patients are in China and among those with NSCLC, approximately 40% have tumours with an EGFR mutation.4-6\n \n \n \n Dave Fredrickson, Executive Vice President, Oncology Business Unit, said: \"The expedited approval of Tagrisso in China as part of a curative-intent regimen for early-stage EGFR-mutated lung cancer un...