Clinical Trials - August 12, 2019
Positive results about AstraZeneca’s Tagrisso
The company has announced positive overall survival (OS) results from the Phase III FLAURA trial, a randomized, double-blinded, multi-centre trial of Tagrisso (osimertinib) in previously-untreated patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) mutations. Tagrisso showed a statistically-significant and clinically-meaningful improvement in OS, a secondary endpoint […]
Drug Development Pharma - March 31, 2017
Tagrisso receives US FDA full approval
The US Food and Drug Administration 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 on or after an EGFR tyrosine kinase inhibitor (TKI) therapy. […]
Pharma Business - March 29, 2016
AZ’s Tagrisso approved in Japan
The Japanese Ministry of Health, Labour and Welfare has approved Tagrisso (osimertinib, AZD9291) 80mg once-daily tablets for the treatment of patients with epidermal growth factor receptor (EGFR) T790M mutation-positive inoperable or recurrent non-small cell lung cancer (NSCLC) that is resistant to EGFR tyrosine kinase inhibitor (TKI) therapy. Sean Bohen, Executive Vice President, Global Medicines Development […]
Drug Development Pharma - February 3, 2016
AZ granted market authorisation for TAGRISSO
The European Commission has granted conditional marketing authorisation for AstraZeneca’s TAGRISSO, 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 mutation-positive NSCLC, irrespective of previous treatment with an EGFR tyrosine kinase […]
