AstraZeneca is looking to get approval from European regulators for its almost-forgotten oncology agent Iressa as a treatment for locally advanced pre-treated non-small cell lung cancer.

Specifically the Anglo-Swedish drugmaker has submitted a marketing authorisation application to the European Medicines Agency for Iressa (gefitinib) as a treatment for locally advanced or metastatic NSCLC in patients who have been pre-treated with platinum-containing chemotherapy. The application is based on data from the 1,446-patient Phase III INTEREST study.

That trial showed that patients with pre-treated advanced NSCLC who received Iressa had non-inferior overall survival to those treated with intravenous chemotherapy, Sanofi-Aventis’ Taxotere (docetaxel). In addition, AstraZeneca noted that gefitinib had a more favourable tolerability profile than docetaxel and significantly more patients receiving Iressa had an improvement in quality of life.

Furthermore, the firm added that the INTEREST results represent the first time that a tyrosine kinase inhibitor has proven non-inferiority for overall survival relative to chemotherapy in patients with pre-treated advanced NSCLC.

The news represents a return to the spotlight for Iressa, which had first-quarter sales of $58 million and is available in 36 countries. It was previously touted as a blockbuster but those hopes collapsed in 2004 when results from a 1,700-patient study in people with advanced NSCLC who had failed on previous chemotherapy revealed that at the end of one year, just 27% of the Iressa group were still alive compared to 21% of placebo receivers - a non-significant result.

AstraZeneca was allowed to keep the drug on the market in the USA, but its use was heavily restricted and no new patients were allowed access to the therapy unless they were taking part in a clinical trial. The firm withdrew its application to market Iressa in Europe shortly after.