AstraZeneca’s sNDA for Tagrisso granted Priority Review in U.S.

AstraZeneca’s supplemental New Drug Application, sNDA, for has been accepted and granted Priority Review in the US for the treatment of adult patients with unresectable, Stage III epidermal growth factor receptor-mutated non-small cell lung cancer, NSCLC, after chemoradiotherapy, CRT. If approved, Tagrisso will be indicated for EGFRm patients whose tumours have exon 19 deletions or exon 21 mutations. The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is anticipated during the fourth quarter of 2024. The sNDA is based on data from the LAURA Phase III trial recently 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. In the trial, Tagrisso reduced the risk of disease progression or death by 84% compared to placebo as assessed by blinded independent central review. Median progression-free survival was 39.1 months in patients treated with Tagrisso versus 5.6 months for placebo.