The European Commission has granted marketing authorisation for AstraZeneca’s oral anti-cancer drug, IRESSA. It 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 is based on a submissions including two pivotal phase III studies, comparing IRESSA with chemotherapy, IPASS and Interest.
Anders Ekblom, Executive Vice President for Development, AstraZeneca, said: IRESSA is the first targeted treatment for lung cancer, and the EU marketing authorisation today 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.”