AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved Iressa (gefitinib) tablets, 250mg once daily, for the first-line treatment of patients with metastatic non small-cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations, as detected by an FDA-approved test. 

Iressa is an oral, EGFR tyrosine kinase inhibitor (TKI), which works by blocking the activity of the EGFR tyrosine kinase enzyme responsible for regulating signalling pathways implicated in the growth and survival of cancer cells. Iressa was granted Orphan Drug Designation by the FDA in August 2014 for the treatment of EGFR mutation-positive NSCLC.

Antoine Yver, Head of Oncology, Global Medicines Development at AstraZeneca said: “The approval of Iressa provides physicians and patients in the US with a new choice of first-line treatment for metastatic non small-cell lung cancer. AstraZeneca is at the forefront of research into targeted therapies for EGFR mutated lung cancer and is committed to improving the outlook for patients at all stages of the disease.”

For more details, go to: http://www.astrazeneca.com/Media/Press-releases/Article/20150713-iressa-approved-by-us-fda