FDA breathes new life into AZ's lung cancer drug Iressa
This article was originally published in Scrip
Executive Summary
AstraZeneca won approval from the FDA to market Iressa (gefitinib) as a targeted monotherapy for the first-line treatment of patients with advanced or metastatic non-small-cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations, as identified through a companion diagnostic test from Qiagen, which also gained the agency's nod.