Overall Survival was not enough

A 12-1 vote by FDA's Oncologic Drugs Advisory Committee against approving Tarceva erlotinib for first-line maintenance therapy in non-small cell lung cancer was hardly the first time an advisory panel has snubbed a proposed treatment because it appears to have less efficacy than an available drug. But it was the first time in recent memory that ODAC denied a cancer compound that had demonstrated a statistically significant improvement in overall survival.

Indeed, both FDA and OSI Pharmaceuticals Inc. told BioCentury that neither was aware of a previous instance of a cancer agent being turned down despite having demonstrated a statistically significant overall survival (OS) benefit...