AstraZeneca's Iressa gets EU marketing approval

1st Jul 2009 07:24

AstraZeneca has received EU marketing approval for its lung cancer treatment Iressa four years after its was withdrawn from use after disappointing trial data.AstraZeneca said approval has been granted by the European Commission for the treatment of adults with locally advanced or metastatic non-small cell lung cancer across all lines of therapy. The authorisation is based on a submission package that included two pivotal Phase III studies that compared Iressa with chemotherapy.Iressa acts by inhibiting the tyrosine kinase enzyme in the EGFR, thus blocking the transmission of signals involved in the growth and spread of tumours. A mutation in the EGFR is a characteristic occurring in 10-15% of lung cancers in non-Asians, and studies have shown that these types of tumours are particularly sensitive to Iressa, AstraZeneca said."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," Anders Ekblom, Executive Vice President for Development at AstraZeneca added.