AstraZeneca files EU marketing application for Iressa

AstraZeneca has announced that it has filed a marketing application in Europe for the epidermal growth factor receptor (EGFR) inhibitor Iressa (gefitinib) as a treatment for locally advanced non-small cell lung cancer.

The compound has been submitted with the European Medicines Agency as a treatment in patients who have already received treatment with platinum-containing chemotherapy.

AstraZeneca reports that the marketing application is based on data from the phase III Interest study, which showed non-inferior overall survival in pre-treated advanced NSCLC patients who received gefitinib compared to those administered with the intravenous chemotherapy docetexal.

“In addition, gefitinib had a more favourable tolerability profile than docetaxel and significantly more patients receiving gefitinib had an improvement in quality of life,” the company said.

It added that the 1,466-patient Interest study marked the first time that an EGFR tryosine kinase inhibitor had shown non-inferiority for overall survival relative to chemotherapy in this type of patients.

The compound is currently approved for use in 36 countries across the world.

Following the publication of results from the Interest study last September, Dr Edward Kim, assistant professor of medicine at Houston’s MD Anderson Cancer Centre, said that improving efficacy together with minimising toxicity is the future path of cancer treatment.