AstraZeneca re-files NDA for Iressa at FDA for EGFRm Non Small Cell Lung Cancer

AstraZeneca announced that the 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 tumours. AstraZeneca’s NDA submission for Iressa was based on data from the Phase III IFUM1 (IRESSA Follow-Up Measure) clinical trial, providing evidence of Iressa’s efficacy in Caucasian patients. This was supported by results from the IPASS 2 (IRESSA Pan-ASia Study) clinical trial, as well as other collaborative group studies.