ARTICLE | Clinical News

Iressa gefitinib regulatory update

January 12, 2015 8:00 AM UTC

FDA accepted for review an NDA from AstraZeneca for Iressa gefitinib as monotherapy for first-line treatment of EGFR mutation-positive, advanced or metastatic non-small cell lung cancer (NSCLC). The PDUFA date is in 3Q15. The EGFR tyrosine kinase inhibitor is approved in 90 countries. ...