FDA Accepts AZ' Filing for First-Line Iressa

The gist: A drug called gefitinib (Iressa) may soon be available in the U.S. as an initial treatment choice for people with advanced or metastatic non-small cell lung cancer (NSCLC) that tests positive for an EGFR mutation. The drug is already approved in many other countries. But in the U.S., only people who have already taken it successfully as part of a clinical trial or expanded access program currently have access to it. The company that makes gefitinib has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA). The FDA will decide whether or not to approve gefitinib as a first-line treatment in late 2015.

“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.”