PHILADELPHIA The drug gefitinib (Iressa) was approved by the U.S. Food and Drug Administration (FDA) in May 2003 under the agencys accelerated approval program for the treatment of patients with non-small cell lung cancer (NSCLC) who had failed two or more courses of chemotherapy. Consistent with the requirements of accelerated approval, the sponsoring company continued to study the drug to verify the expected clinical benefit. In December 2004, the FDA released a statement notifying the failure of a large clinical trial of gefitinib to show an overall survival advantage compared to placebo in treating patients with lung cancer. In June 2005, FDA issued a new label for gefitinib that limits use to patients with cancer who in the opinion of their treating physician, are currently benefiting, or have previously benefited, from Iressa treatment.

However, oncologists believe that Iressa still holds promise and continue investigating its potential. Several studies presented at the Annual International Conference on Molecular Targets and Cancer Therapeutics coordinated by the American Association for Cancer Research (AACR), the National Cancer Institute (NCI) and the European Organisation for Research and Treatment of Cancer (EORTC) explore the ways in which gefitinib may work on tumors and which patients may benefit the most.

These include:

• Molecular markers may be the key to ensuring successful treatment with gefitinib.
• Lung cancer patients with these markers may have a greater chance of survival benefit with gefitinib treatment.
• Lung cancer patients chance of survival with gefitinib may lie with an inherited genetic contribution in patients with a good disease performance status.

Epidermal Growth Factor (EGFR), K-Ras and B-Raf Mutation Status and Clinical Outcome to Gefitinib (Iressa) in Phase III Place
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Contact: Warren R. Froelich
froelich@aacr.org
215-440-9300
American Association for Cancer Research
15-Nov-2005