The intial May 2003 FDA approval of Iressa was based upon data from Phase II trials that showed that 13.6 % of patients had achieved a minimum 50% tumor shrinkage. Patients in these trials had received Iressa after disease progression following failure of both platinum-based and docetaxel chemotherapies. The NEJM and Science publications essentially attempt to provide a molecular explanation for why some patients respond so well to Iressa and others experience absolutely no response whatsoever. The concept of targeted cancer therapy, although clearly in the early stages of its development, will certainly be advanced because of these findings.

Iressa is an orally active epidermal growth factor receptor (EGFR) inhibitor. EGFR is expressed in cancerous cells of the lung. When stimulated, it is thought to play a role in cancer cell proliferation, metastasis, and tumor resistance to chemo and radiotherapies. Iressa is thought to exert its effect by inhibiting EGFR and preventing it from activating damaging cell signaling pathways.

There will be in excess of 145,000 new cases of lung cancer diagnosed in the United States this year, and in excess of 150,000 deaths due to this disease. Of these, 80-85% will be NSCLC. Most patients are in the advanced stage of the disease at the time of diagnosis and are offered chemotherapy.

Iressa is the first EGFR inhibitor approved for use in the United States. Until the NEJM and Science online publications were released, its low rate of tumor response diminished the drug’s overall efficacy. However, the screening of candidates for specific EGFR mutations may dramatically increase effectiveness in health systems. As such, Biohorizon recommends commencement of organization specific assessment activities in the near term.

Technology Details
Target Disease / Indication: Non Small Cell Lung Cancer
Technology Classification: Drug
Body System: Respiratory System
Program Area: Medicine/Oncology
Regulatory Status: Approved
BioHorizon Impact Score: 70/100 – High