Tagrisso approved in the EU for the adjuvant treatment of patients with early-stage EGFR-mutated lung cancer.- AstraZeneca

Tagrisso is indicated for EGFRm patients whose tumours have exon 19 deletions or exon 21 (L858R) mutations. The approval by the European Commission was based on positive results from the ADAURA Phase III trial in which 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 trial also showed a statistically significant and clinically meaningful improvement in DFS for Tagrisso in the overall trial population, a key secondary endpoint. 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 disease recurrence within five years. About a fifth of the world’s lung cancer patients are in the EU and among those with NSCLC, approximately 15% have tumours with an EGFR mutations.