FDA accepts NDA filing from AstraZeneca for Iressa

2 December 2014

The US Food and Drug Administration has accepted for filing the New Drug Application from Iressa (gefitinib) from Anglo-Swedish drug major AstraZeneca (LSE: AZN).

Iressa is a targeted monotherapy for first-line treatment of patients with advanced or metastatic epidermal growth factor receptor mutation positive non-small cell lung cancer. It has a Prescription Drug User Fee Act goal date in the third quarter of 2015.

It 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 IFUM (Iressa Follow-Up Measure) clinical trial, providing evidence of Iressa’s efficacy in Caucasian patients. This was supported by results from the IPASS (Iressa Pan-ASia Study) clinical trial, as well as other collaborative group studies.

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