FDA Accepts AstraZeneca’s NDA for IressaBy
AstraZeneca reports that the US Food and Drug Administration (FDA) has accepted for filing the 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. The Prescription Drug User Fee Act goal date for Iressa will be in the third quarter 2015.
Iressa is an EGFR tyrosine kinase inhibitor that acts by blocking the transmission of signals involved in the growth and spread of tumors. Iressa is already approved in 90 countries for the treatment of adult patients with locally advanced or metastatic NSCLC with activating mutations of the EGFR tyrosine kinase. Iressa was first approved by the FDA in 2003.