- Iressa (gefitinib) tablets are approved for first-line use in patients with metastatic non-small cell lung cancer (NSCLC).
- AstraZeneca (AZ) received orphan drug designation for Iressa in August 2014 for treatment of EGFR-positive NSCLC.
- Iressa is approved in 91 countries.
So here's what's interesting about Iressa: A lot. First of all, this drug truly is a targeted monotherapy, and is intended for first-line treatment. Specifically, it is intended to be used in patients with locally advanced or metastatic EGFR mutation-positive NSCLC. In addition, Iressa comes with a companion diagnostic, co-developed by AZ and Qiagen. Using this test, clinicians can rapidly identify EGFR mutation status by testing a small tissue sample.
FDA approval is based on the strength of a phase IV study involving 106 patients with locally advanced or metastatic EGFR mutation-positive NSCLC. In this study, Iressa-treated patients had an overall response rate of 70%---meaning that they had some tumor shrinkage. The next goal with Iressa is to gain approvals for combo therapies to expand the indication.