US FDA Nods AstraZeneca's Tagrisso for patients with unresectable

Tagrisso (osimertinib) from AstraZeneca has been given the approval in the US to treat adult patients with unresectable, Stage III EGFRm NSCLC who have not seen their disease worsen after platinum-based CRT. Tagrisso is approved for individuals who have exon 19 deletions or exon 21 (L858R) mutations, as identified by an FDA-recognized test.

Approval was granted after the FDA conducted a Priority Review of data from the LAURA phase III clinical trial, which was showcased during the Plenary Session at the 2024 ASCO Annual Meeting and also published in The New England Journal of Medicine.

Tagrisso lowered the chances of disease advancement or mortality by 84% compared to a fake treatment (hazard ratio 0.16; 95% confidence interval 0.10-0.24; p<0.001) as evaluated by a neutral central review. Tagrisso treatment resulted in patients experiencing a median progression-free survival (PFS) of 39.1 months, compared to 5.6 months with the placebo. Overall, the results for overall survival (OS) are still not fully developed in this analysis. The trial is ongoing to evaluate OS as a secondary outcome.

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.”