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EU Approval of Tagrisso Sets New Standard for EGFR-Mutated NSCLC Treatment

NextEdge Admin

24 Dec 2024

2 min 3 sec

AstraZeneca’s Tagrisso (osimertinib) has received EU approval for treating adults with locally advanced, unresectable non-small cell lung cancer (NSCLC) harboring EGFR exon 19 deletions or exon 21 (L858R) mutations, whose disease has not progressed following platinum-based chemoradiation therapy (CRT). The approval, following the Committee for Medicinal Products for Human Use's positive opinion, is based on the LAURA Phase III trial, published in The New England Journal of Medicine.

In the trial, Tagrisso reduced the risk of disease progression or death by 84% compared to placebo (hazard ratio 0.16; p<0.001). Median progression-free survival (PFS) was 39.1 months versus 5.6 months for placebo. Overall survival (OS) results remain immature, and the trial is ongoing to assess OS as a secondary endpoint. The safety profile was consistent with previous findings, with no new safety concerns.

This is a significant milestone for NSCLC patients in Europe, where over 450,000 lung cancer cases are diagnosed annually, 80-85% of which are NSCLC. Approximately 10-15% of NSCLC cases involve EGFR mutations. Tagrisso is now the first EGFR inhibitor approved in this setting, setting a new standard of care and highlighting the importance of timely EGFR testing. Already approved in over 100 countries, Tagrisso is a cornerstone therapy for EGFR-mutated NSCLC in various stages.