BioCentury
ARTICLE | Clinical News

EC approves Tagrisso for NSCLC

June 15, 2018 8:23 PM UTC

AstraZeneca plc (LSE:AZN; NYSE:AZN) said the European Commission approved Tagrisso osimertinib as a first-line treatment in adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have EGFR mutations.

The approval was based on data from the Phase III FLAURA trial, in which Tagrisso met the primary endpoint of improving progression-free survival (PFS) vs. standard of care (SOC) in the first-line setting. In April, FDA approved Tagrisso in the indication (see BioCentury, Sept. 14, 2017)...