AstraZeneca: European Agency Accepts Variation to Application for Tagrisso
AstraZeneca PLC (AZN.LN) said Tuesday that the European Medicines Agency has accepted a variation to its marketing-authorization application for Tagrisso, for treatment of adult patients with locally-advanced or metastatic non-small cell lung cancer.
The pharmaceutical company said the drug application, which is an epidermal growth factor receptor inhibitor, was based on data from the phase 3 trial, in which Tagrisso significantly improved progression-free survival compared to current treatments.
On Monday, AstraZeneca reported the submission of a supplemental new drug application to Japan's Pharmaceuticals and Medical Devices Agency for the use of Tagrisso.
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(END) Dow Jones Newswires
November 28, 2017 02:30 ET (07:30 GMT)