Regulatory approval of anti-cancer drugs occurs typically after demonstration of clinical benefit in registration trials. Over the last 15 years, new drug development has focused on numerous mechanisms of action including conventional cytotoxic agents, inhibition of oncogenic signaling pathways, angiogenesis and immune modulation. In recent years, there has been substantial enthusiasm for immunotherapy agents [1–4]. However, the differential efficacy, safety, tolerability and price of these agents relative to other anti-neoplastic drugs are uncertain.
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