AstraZeneca's Iressa under FDA review for 2nd US chance
This article was originally published in Scrip
Executive Summary
The FDA accepted for review AstraZeneca's new drug application (NDA) for Iressa (gefitinib) as a targeted monotherapy for the first-line treatment of patients with advanced or metastatic epidermal growth factor receptor mutation positive (EGFRm) non-small cell lung cancer (NSCLC), as identified through a companion diagnostic test.