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AstraZeneca’s Tagrisso Recommended for Approval in EU for Unresectable EGFR-Mutated NSCLC

NextEdge Admin

19 Nov 2024

2 min 18 sec

AstraZeneca’s Tagrisso (osimertinib) has received a positive recommendation from the European Medicines Agency’s CHMP for treating adults with locally advanced, unresectable non-small cell lung cancer (NSCLC) harboring EGFR exon 19 deletions or exon 21 (L858R) mutations. The approval is for patients whose disease has not progressed after platinum-based chemoradiation therapy (CRT).

The recommendation is based on the LAURA Phase III trial, published in *The New England Journal of Medicine*. Tagrisso demonstrated an 84% reduction in disease progression or death compared to placebo (HR 0.16; 95% CI 0.10-0.24; p<0.001), with a median progression-free survival (PFS) of 39.1 months versus 5.6 months for placebo. Overall survival (OS) data remain immature, with further analysis ongoing.

Lung cancer affects over 450,000 people annually in Europe, with 10-15% of NSCLC patients having EGFR mutations. Nearly 20% of NSCLC cases are unresectable. Dr. Manuel Cobo highlighted the significant efficacy of osimertinib as the first targeted therapy in this setting, offering over three years of disease control.

Tagrisso’s safety profile in the LAURA trial was consistent with previous studies, with no new concerns. Already approved for multiple EGFRm NSCLC indications in over 100 countries, including the US and EU, it continues to demonstrate benefit across all stages of EGFR-mutated NSCLC. Regulatory reviews for this new indication are ongoing in China, Japan, and other nations. This development marks a crucial step in improving outcomes for patients with EGFR-mutated NSCLC.