AstraZeneca’s Tagrisso gets US approval for patients with EGFRm NSLC

AstraZeneca’s TAGRISSO or osimertinib, has been approved in the US for the treatment of adult patients with unresectable, Stage III epidermal growth factor receptor-mutated or EGFRm, non-small cell lung cancer NSCLC whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy or CRT. 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 Food and Drug Administration 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… Overall survival results remain immature at this current analysis. The trial continues to assess OS as a secondary endpoint. ..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.”