Shots:

• The approval is based on the P-III ADAURA trial assessing Tagrisso (80mg- qd) vs PBO in 682 patients with stage IB- II- IIIA EGFRm NSCLC following complete tumor resection and adjuvant chemotherapy as indicated
• Results: reduction in the risk of disease recurrence (83%); DFS results in the overall trial population in reducing the risk of disease recurrence (80%); @2 yrs. disease-free and alive patients (89% vs 52%)
• Tagrisso is an irreversible EGFR-TKI with clinical activity against CNS metastases and has received the US FDA BTD for patients in the early-stage disease setting. The therapy is under PR in China and regulatory review in the EU

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