In final draft guidance, the National Institute for Health and Care Excellence (NICE) has rejected Tagrisso, because the survival benefits...
The European Commission has granted marketing authorisation for Tagrisso (osimertinib) as monotherapy for the 1st-line treatment of adult patients with...
The EU Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional...
FDA accepts sBLA for review of Tagrisso for first line treatment of metastatic NSCLC
Results from a prespecified exploratory analysis of the FLAURA2 Phase III trial showed AstraZeneca’s Tagrisso (osimertinib) with the addition of chemotherapy demonstrated a 42% improvement in central nervous system (CNS) progression-free survival (PFS), compared to Tagrisso alone for patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) and brain metastases at baseline, representing 40% of patients in the trial, as assessed by blinded independent central review (BICR).
AstraZeneca announced positive overall survival (OS) results from the Phase III FLAURA trial, a randomised, double-blinded, multi-centre trial of Tagrisso...
The ADAURA Phase III trial for Tagrisso (osimertinib) in the adjuvant treatment of patients with Stage IB.
AstraZeneca presented new post-progression outcomes data from an exploratory analysis of the global Phase III FLAURA trial, which assessed the...
AstraZeneca presente detailed overall survival (OS) results from the Phase III FLAURA trial of Tagrisso (osimertinib) in the 1st-line treatment...