Tagrisso (osimertinib) approved in the US for patients with unresectable, Stage III EGFR-mutated lung cancer

Tagrisso is indicated for patients with exon 19 deletions or exon 21 (L858R) mutations, as detected by a FDA-approved test.. The approval follows a Priority Review by the FDA that was based on results from the LAURA Phase III trial, which were presented during the Plenary Session at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in The New England Journal of Medicine. (previously cited)

Tagrisso reduced the risk of disease progression or death by 84% compared to placebo (hazard ratio 0.16; 95% confidence interval 0.10-0.24; p<0.001) as assessed by blinded independent central review. Median progression-free survival (PFS) was 39.1 months in patients treated with Tagrisso versus 5.6 months for placebo. Overall survival (OS) results remain immature at this current analysis. The trial continues to assess OS as a secondary endpoint.

Each year in the US, there are more than 200,000 people diagnosed with lung cancer, and 80-85% of these patients are diagnosed with NSCLC, the most common form of lung cancer. Approximately 15% of NSCLC patients in the US have EGFR mutations. Nearly one in five people diagnosed with NSCLC has an unresectable tumour.

Suresh Ramalingam, MD, Executive Director of Winship Cancer Institute of Emory University, Atlanta, US, and principal investigator in the trial, said: “This approval represents a major breakthrough for patients with Stage III, EGFR-mutated lung cancer who will now have the opportunity to benefit from osimertinib. Patients treated with osimertinib lived without disease progression by more than three years in the LAURA trial, and this impressive benefit underscores the importance of diagnosing and testing lung cancer patients as early as possible.”