Tag Archives: Tagrisso

April, 2018

19 April
FDA Approves AstraZeneca’s Tagrisso as First-Line Therapy for EGFR-Mutated Non-Small Cell Lung Cancer

AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved Tagrisso (osimertinib) for the 1st-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) mutations, (exon 19 deletions or exon 21 L858R mutations), as detected by an FDA-approved test. The …
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18 December
FDA Grants Priority Review to AstraZeneca’s Tagrisso in First-Line EGFR-Mutated Non-Small Cell Lung Cancer

WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca today announced that the US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) for the use of TAGRISSO® (osimertinib), a third-generation, irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) with clinical activity against central nervous system (CNS) metastases, in the 1st-line …
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10 October
FDA Grants Breakthrough Therapy Designation to AstraZeneca’s Tagrisso for EGFR Mutated NSCLC

AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for Tagrisso (osimertinib) for the 1st-line treatment of patients with metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC). Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at …
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27 July
AstraZeneca’s Tagrisso Significantly Improves Progression-Free Survival in Late-Stage NSCLC Study

AstraZeneca today announced that the Phase III FLAURA trial showed a statistically-significant and clinically-meaningful progression-free survival (PFS) benefit with Tagrisso (osimertinib) compared to current 1st-line standard-of-care treatment (erlotinib or gefitinib) in previously-untreated patients with locally-advanced or metastatic epidermal growth factor receptor mutation-positive (EGFRm) non-small cell lung cancer (NSCLC). Sean Bohen, Executive Vice …
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7 June
AstraZeneca Presents Tagrisso Data in EGFR T790M-Mutation Positive NSCLC & CNS Metastases

WILMINGTON, Del.–(BUSINESS WIRE)–AstraZeneca today reported further evidence that Tagrisso® (osimertinib), the potential new standard of care for patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), also shows clinical activity in those patients with disease progression to central nervous system (CNS) metastases. The data, …
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31 March
FDA Grants Full Approval to AstraZeneca’s NSCLC Drug Tagrisso

AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted full approval for Tagrisso (osimertinib) 80mg once-daily tablets, for the treatment of patients with metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test, whose disease has progressed …
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18 July
AstraZeneca’s Tagrisso Meets Main Goal in Late-Stage Lung Cancer Study

18 July 2016 — AstraZeneca today announced that the Phase III AURA3 trial met its primary endpoint, demonstrating superior progression-free survival (PFS) compared to standard platinum-based doublet chemotherapy. The AURA3 randomised trial assessed the efficacy and safety of Tagrisso as a 2nd-line treatment in more than 400 patients with EGFR T790M …
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3 February
AstraZeneca’s Tagrisso Wins European Approval for Treatment of Lung Cancer

AstraZeneca today announced that the European Commission (EC) has granted conditional marketing authorisation for TAGRISSO™ (AZD9291, osimertinib) 80mg once-daily tablets for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC). Osimertinib is indicated for patients with T790M …
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16 November
FDA Grants Accelerated Approval for AstraZeneca’s Lung Cancer Drug

Today, the U.S. Food and Drug Administration granted accelerated approval for an oral medication to treat patients with advanced non-small cell lung cancer (NSCLC). Tagrisso (osimertinib) is now approved for patients whose tumors have a specific epidermal growth factor receptor (EGFR) mutation (T790M) and whose disease has gotten worse after …
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