‘s supplemental new drug application for Tagrisso has obtained priority review from the US Food and Drug Administration (FDA) for unresectable Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after chemoradiotherapy (CRT). On receipt of approval, the product will be used to treat patients whose tumours have exon 19 deletions or exon 21 (L858R) mutations. The gold standard of business intelligence.
A decision on the approval of the product under the Prescription Drug User Fee Act is expected in the fourth quarter of 2024. The sNDA submission is supported by results from the double-blind, randomised, placebo-controlled, multi-centre, global LAURA Phase III trial. Participants received Tagrisso 80mg once daily oral tablets until experiencing disease progression or unacceptable toxicity, or meeting other discontinuation criteria.
Patients in the placebo group were allowed to switch to Tagrisso upon disease progression. Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research.
Gain competitive edge. Your download email will arrive shortly We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form The trial involved 216 patients across 145 centres in more than 15 countries.
Tagrisso lowered disease progression or mortality ris.