FDA Approves Iressa to Treat Non-Small Cell Lung Cancer
A breakthrough in how we treat lung cancer could be imminent.
The U.S. Food and Drug Administration (FDA) has issued an approval for Iressa (gefitinib), a drug use for the first-line treatment of patients with metastatic non-small cell lung cancer (NSCLC). The drug targets specific types of epidermal growth factor receptor (EGFR) gene mutations.
Lung cancer is the leading cause of cancer-related death among men and women in the U.S. The National Cancer Institute estimates that about 221,000 Americans will be diagnosed with the disease this year, while 158,000 will die from lung cancer. NSCLC is the most common type of lung cancer, and mutations in the EGFR gene are present in about ten percent of cases.
"Iressa offers another effective first-line therapy option for selected lung cancer patients. This approval provides further support for a highly targeted approach to treating cancer," Richard Pazdur said in a written statement. Pazdur is the director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research.
The FDA granted Iressa an orphan product designation, a label given to drugs intended to treat rare diseases. The designation provides financial incentives like tax credits, user fee waivers, and eligibility for market exclusivity to promote development.
The effectiveness and safety of Iressa was demonstrated in a multi-center, single-arm clinical trial of 106 patients with previously untreated, EGFR mutation-positive metastatic NSCLC. Results showed that tumors shrank in about 50 percent of patients after treatment and this effect lasted an average of six months. These results were supported by a retrospective analysis of another clinical trial, which identified a subgroup of 186 patients with EGFR mutation-positive metastatic NSCLC receiving first-line treatment.
Iressa may cause serious side effects including interstitial lung disease, liver damage, gastrointestinal perforation, severe diarrhea and ocular disorders. The most common side effects of Iressa are diarrhea and skin reactions (including rash, acne, dry skin and pruritus, or itching).