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 approach to treating cancer”.
The open-label IPASS trial subset data, which involved 1217 metastatic non-small cell lung cancer (NSCLC) patients out of which 186 EGFR-positive patients enrolled, also support this approval.
In 2003, IRESSA (gefitinib) get accelerated approval for the treatment of patients with advanced NSCLC after progression on platinum doublet chemotherapy and docetaxel.
IRESSA (gefitinib) may cause side effects like liver damage, interstitial lung disease, gastrointestinal perforation severe diarrhea and ocular disorders. Diarrhea and skin reactions are the most common side effect of gefitinib including rash, acne, dry skin and pruritus, or itching.
But this is great news for metastatic lung cancer patients, as lung cancer is a leading cause of death among men and women. Lung cancer is more common in men but the death rate among women increases. NSCLC is a most common type of lung cancer and about 10 percent of mutations in the EGFR are present in NSCLC. We hope that with the approval of this IRESSA (gefitinib) by FDA death rate among metastatic non-small cell lung cancer (NSCLC) patients decreases.