BioCentury
ARTICLE | Clinical News

Japan approves Tagrisso for first-line NSCLC

August 31, 2018 6:59 PM UTC

AstraZeneca plc (LSE:AZN; NYSE:AZN) said Japan's Ministry of Health, Labour and Welfare (MHLW) approved Tagrisso osimertinib as a first-line treatment for recurrent EGFR mutation-positive non-small cell lung cancer. The drug was already approved in Japan to treat EGFR T790M mutation-positive recurrent NSCLC that is resistant to first-line EGFR inhibitors.

MHLW based its approval 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 in the first-line setting (see “AZ reports detailed first-line NSCLC data from Phase III FLAURA trial of Tagrisso”)...