New Hope for Lung Cancer Patients with FDA Approval of Gefitinib
In July 15, the U. S. Food and Drug (FDA) Administration 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 with an exon 19 deletion or exon 21 (L858R) substitution. The approval is based on the single-arm phase IV IFUM trial in which gefitinib had an overall response rate of 50% in 106 treatments. This overall response rate was measured by the investigators and an independent review panel, the independent review panel report say that a median duration of response of 6.0 months while the investigators report shown higher overall response rate and median duration of response i.e., 70% and 8.3 months respectably. Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research said that "This approval of gefitinib provides further support for a highly targeted