AstraZeneca's Tagrisso Label Expansion Filing Accepted By EMA
Zacks Investment Research | Nov 28, 2017 09:52PM ET
AstraZeneca Plc. (NYSE:AZN) announced that the European Medicines Agency (EMA) has accepted a variation to the Marketing Authorisation Application (MAAv) for the label expansion of Tagrisso (osimertinib). AstraZeneca is looking to get Tagrisso approved for the first-line treatment of adult patients with locally-advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have EGFR mutations.
Tagrisso is already approved in the United States, European Union, Japan and China as a second-line treatment option for patients with EGFR mutation-positive NSCLC.
The label expansion regulatory application was based on data from the phase III FLAURA study, evaluating Tagrisso compared with the standard-of-care EGFR tyrosine kinase inhibitor (TKI) therapy in the first-line lung cancer setting.
The data showed that treatment with Tagrisso reduced the risk of progression or death by more than half compared with the commonly-used EGFR inhibitors for the first-line treatment of patients with EGFR mutation-positive NSCLC. The median progression-free survival (PFS) was 18.9 months for patients on Tagrisso as compared to 10.2 months in the comparator arm. Tagrisso was well-tolerated in the trial with a safety profile, consistent with the previous experience.
So far this year, AstraZeneca’s shares have outperformed the industry. The stock has been up 22.7% compared with the Zacks Investment Research
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