FDA Expands Approval of Osimertinib in Lung Cancer

FDA Expands Approval of Osimertinib in Lung Cancer

The FDA has approved osimertinib (Tagrisso) for locally advanced, unresectable stage III non-small cell lung cancer (NSCLC) following chemoradiotherapy, the

FDA Approves Osimertinib for Unresectable EGFR-Mutated Lung Cancer

The decision is based on positive results from the phase 3 LAURA trial.

Tagrisso approved in the US for patients with unresectable, Stage III EGFR-mutated lung cancer - Pipelinereview

Based on LAURA Phase III trial results which showed Tagrisso extended median progression-free survival by more than three years   LONDON, UK I September 26, 2024 I 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 seq…

FDA Approves Osimertinib in Stage III EGFR-Mutated NSCLC

Osimertinib is now an FDA-approved therapy for stage III NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations that did not progress during or following platinum-based chemoradiation.

FDA Approves Tagrisso for Some With Advanced NSCLC

Tagrisso has been approved for some adults with locally advanced, unresectable stage 3 non-small cell lung cancer.

FDA Approves Osimertinib in Advanced EGFR+ NSCLC

Findings from the phase 3 LAURA trial support the approval of osimertinib for advanced EGFR-mutated NSCLC.