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TAGRISSO® ( OSIMERTINIB ORAL By ASTRAZENECA ) Approved in The US For Patients With Unresectable, Stage III EGFR-Mutated Lung Cáncer .
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Based on LAURA Phase III Trial Results Which Showed TAGRISSO Extended Median Progression-Free Survival By More Than Three Years .
WILMINGTON, Del.--(BUSINESS WIRE)--AstraZeneca’s TAGRISSO® (osimertinib) has been approved in the US for the treatment of adult patients with unresectable, Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy (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 (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.
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 . ...