Results from the FLAURA2 Phase III trial showed AstraZeneca’s Tagrisso (osimertinib) with the addition of chemotherapy, provided a clinically meaningful and consistent benefit in subsequent outcomes after disease progression in patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) .
AstraZeneca has announced that the European Medicines Agency has accepted a variation to the Marketing Authorisation Application (MAAv) for Tagrisso.
AstraZeneca presente detailed overall survival (OS) results from the Phase III FLAURA trial of Tagrisso (osimertinib) in the 1st-line treatment...
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).
In final draft guidance, the National Institute for Health and Care Excellence (NICE) has rejected Tagrisso, because the survival benefits...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...
Results from an exploratory analysis of the positive ADAURA Phase III trial showed AstraZeneca’s Tagrisso (osimertinib) extended disease-free survival (DFS) in patients with epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) regardless of prior adjuvant chemotherapy treatment or stage of disease, building on the unprecedented primary DFS results for Tagrisso in the adjuvant setting announced last year.
AstraZeneca announced that the Phase III FLAURA trial showed a statistically-significant and clinically-meaningful progression-free survival (PFS) benefit with Tagrisso (osimertinib)...
The EU Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a conditional...