AstraZeneca: wins FDA breakthrough therapy for Tagrisso.
(CercleFinance.com) - AstraZeneca has received breakthrough therapy designation from the US Food and Drug Administration for an investigational treatment for a certain form of non-small cell lung cancer, the drugmaker said on Monday.
The FDA has granted the designation for Tagrisso for the first-line treatment of patients with metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC).
The decision was based on data from a Phase III trial that showed that median progression-free survival was nearly double at 18.9 months for Tagrisso compared with 10.2 months for current first-line treatment.
Approximately 30%-40% of patients in Asia have EGFR-mutated lung cancer.
Copyright (c) 2017 CercleFinance.com. All rights reserved.
The FDA has granted the designation for Tagrisso for the first-line treatment of patients with metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC).
The decision was based on data from a Phase III trial that showed that median progression-free survival was nearly double at 18.9 months for Tagrisso compared with 10.2 months for current first-line treatment.
Approximately 30%-40% of patients in Asia have EGFR-mutated lung cancer.
Copyright (c) 2017 CercleFinance.com. All rights reserved.