US regulators have accepted AstraZeneca’s New Drug Application for Iressa (gefitinib) as a targeted monotherapy for the first-line treatment of certain lung cancer patients.

The drug giant is seeking approval to market Iressa for the treatment of patients with advanced or metastatic non-small cell lung cancer (NSCLC) who test positive for an epidermal growth factor receptor mutation (EGFRm).  

AZ is working with Qiagen in the US to develop a companion diagnostic test to guide the use of Iressa in this setting; In Europe, their collaboration resulted in the drug becoming the first EGFR tyrosine kinase inhibitor to have a European label allowing the use of circulating tumour DNA (ctDNA) obtained from a blood sample, to be used for the assessment of EGFR mutation status in those patients where a tumour sample is not an option.

Iressa is an EGFR tyrosine kinase inhibitor that blocks the transmission of signals involved in the growth and spread of tumours. The drug was first approved in 2002 and is already cleared in 90 countries for the treatment of adults with with locally advanced or metastatic NSCLC with activating mutations of the EGFR tyrosine kinase.

The FDA should make its decision on Iressa known in the third quarter 2015.