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The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.
The U.S. Food and Drug Administration today approved Iressa (gefitinib) for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors harbor specific types of epidermal growth factor receptor (EGFR) gene mutations, as detected by an FDA-approved test.
Lung cancer is the leading cause of cancer-related death among men and women in the U.S. and, though more common in men, the number of deaths from lung cancer in women is increasing. According to the National Cancer Institute, an estimated 221,200 Americans will be diagnosed with lung cancer, and 158,040 will die from the disease this year. NSCLC is the most common type of lung cancer. Mutations in the EGFR gene are present in about 10 percent of NSCLC tumors.
Iressa is a kinase inhibitor that blocks proteins that promote the development of cancerous cells with certain EGFR mutations. It is intended for the treatment of patients whose tumors express the most common types of EGFR mutations in NSCLC (exon 19 deletions or exon 21 L858R substitution gene mutations). The therascreen EGFR RGQ PCR Kit was approved as a companion diagnostic test to identify patients with tumors having the EGFR gene mutations in order to determine which patients would be appropriate for treatment with Iressa.
The FDA granted Iressa orphan product designation for the treatment of EGFR mutation-positive metastatic NSCLC. Orphan product designation is given to drugs intended to treat rare diseases, which provides financial incentives – like tax credits, user fee waivers, and eligibility for market exclusivity – to promote their development.
The efficacy and safety of Iressa for this use was demonstrated in a multi-center, single-arm clinical trial of 106 patients with previously untreated, EGFR mutation-positive metastatic NSCLC. The study’s primary endpoint was objective response rate, or the percentage of patients who experienced complete and partial shrinkage or disappearance of the tumors after treatment. Participants received Iressa 250 mg once daily. Results showed that tumors shrank in about 50 percent of patients after treatment and this effect lasted an average of six months. The response rates were similar in patients whether their tumors had EGFR exon 19 deletions or exon 21 L858R substitution mutations.
For more information, please visit: Iressa
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