Scientific Publications by FDA Staff

N Engl J Med 2016 May 26;374(21):2001-3

Seamless oncology-drug development.

Prowell TM, Theoret MR, Pazdur R

For more than half a century, the clinical development of anticancer drugs has followed a predictable and orderly set of sequential stages: phase 1 trials were designed to determine the drug's safety, tolerability, and dose; phase 2 trials then explored the drug's activity in a variety of cancers; and phase 3 trials compared the new drug with existing treatments and served as the basis for regulatory approval. Advances in our understanding of cancer biology in the past decade have led to both development of more effective drugs and improved patient selection made possible by early biomarker discovery and companion diagnostic . . .