AstraZeneca's oral anti-cancer drug Iressa has been granted marketing authorisation by the European Commission.
Iressa is used for the treatment of adults with locally advanced or metastatic non-small cell lung cancer, with activating mutations of EGFR-TK across all lines of therapy.
The authorisation by the European Commission was based on submissions including two pivotal Phase III studies that compared Iressa with chemotherapy, IPASS and Interest.
AstraZeneca executive vice-president for development Anders Ekblom said that Iressa is the first targeted treatment for lung cancer, and the EU marketing authorisation represents an important step forward in the treatment of this devastating disease.
"For the first time, patients with EGFR mutation positive tumours will have a more effective and better-tolerated alternative to chemotherapy as a first-line treatment," Ekblom said.