Drug approval challenges in the age of personalized cancer treatment

Abstract

Cancer treatment is in evolution from nonspecific cytotoxic drugs that damage both tumor and normal cells to more targeted agents and immunotherapy approaches that target unique molecular features of cancer cells or that modulate the tumor immune response to produce greater effectiveness with less toxicity. The development and use of such approaches in biomarker-defined populations enables a more personalized approach to cancer treatment than previously possible and potentially improves the effectiveness, reduces the toxicity and lowers the cost of cancer care although significant barriers remain to realizing the vision of personalized cancer treatment.