Approval Summary for Erlotinib for Treatment of Patients with LocallyAdvanced orMetastatic Non^Small Cell Lung Cancer after Failure of at Least One Prior Chemotherapy Regimen

Abstract Purpose:To describe the Food and Drug Administration (FDA) review and approval of erlotinib (Tarceva, OSI Pharmaceuticals, Melville, NY) for treatment of patients with locally advanced or metastatic non ^ small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regimen. Experimental Design: The FDA reviewed raw data in electronic format from a randomized controlled clinical trial comparing erlotinib with placebo in patients with locally advanced or metastatic NSCLC after failure of at least one prior chemotherapy regimen. Results: Patients were randomized in a 2:1 ratio (erlotinib, n = 488 and placebo, n = 243). Erlotinib was superior to placebo for survival, progression-free survival, and tumor response rate. Exploratory analyses indicate that epidermal growth factor receptor status may be an important predictor of the erlotinib survival effect. Rash (75 % versus 17%) and diarrhea (54% versus 18%) in the erlotnib and placebo group respectively were the most common adverse events. Severe rash occurred in 9 % and severe diarrhea in 6 % of erlotinib-treated patients and each resulted in study discontinuation in 1 % of patients. Dose reductions were required for 10% of patients with rash and 4 % of patients with diarrhea