The European Commission has approved Tagrisso combined with chemotherapy as a first-line treatment for patients with advanced EGFR-mutated NSCLC. Lung cancer diagnoses in Europe exceed 450,000 annually, with EGFR mutations present in 10%-15% of NSCLC patients in the US and Europe. Tagrisso is a third-generation EGFR-TKI that has shown significant clinical activity in NSCLC, including efficacy against CNS metastases. FLAURA2 trial data supported the approval, showing a 38% reduction in disease progression or death risk with Tagrisso and chemotherapy compared to Tagrisso alone. Tagrisso is also approved in other countries for first-line EGFR-mutated NSCLC treatment and is under global regulatory review for stage III NSCLC.
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