EU Advances Tagrisso for Lung Cancer

AstraZeneca's Tagrisso (osimertinib) has received a recommendation for approval in the European Union to treat adult patients with unresectable, EGFR-mutated non-small cell lung cancer (NSCLC) following platinum-based chemoradiation therapy. The approval is based on the LAURA Phase III trial, which showed Tagrisso reduced disease progression risk by 84%, extending median progression-free survival (PFS) to 39.1 months versus 5.6 months for placebo.

The trial highlights Tagrisso’s potential to address the unmet need in EGFR-mutated NSCLC, a disease affecting around 10-15% of NSCLC patients in Europe. While overall survival data remains immature, the results strengthen Tagrisso’s position as a critical therapy for EGFR-mutated lung cancer.

Already approved for similar indications in the U.S., Tagrisso’s safety profile remains consistent with no new concerns identified. Regulatory applications for this indication are under review in multiple countries, including China and Japan. The drug is currently approved in over 100 countries for various stages of EGFR-mutated NSCLC.