BioCentury
ARTICLE | Clinical News

Iressa gefitinib regulatory update

July 20, 2015 7:00 AM UTC

FDA approved an NDA from AstraZeneca for Iressa gefitinib for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations. AZ plans to launch the EGFR tyrosine kinase inhibitor in the U.S. this week. Iressa is approved in 91 countries for EGFR mutation-positive NSCLC. ...