Developing standards for breakthrough therapy designation in oncology.

  title={Developing standards for breakthrough therapy designation in oncology.},
  author={Sandra J. Horning and Daniel A. Haber and Wendy Selig and S Percy Ivy and Samantha A. Roberts and Jeff D. Allen and Ellen V. Sigal and Charles L Sawyers},
  journal={Clinical cancer research : an official journal of the American Association for Cancer Research},
  volume={19 16},
In July 2012, Congress passed the Food and Drug Administration Safety and Innovation Act (FDASIA). The Advancing Breakthrough Therapies for Patients Act was incorporated into a Title of FDASIA to expedite clinical development of new, potential "breakthrough" drugs or treatments that show dramatic responses in early-phase studies. Using this regulatory pathway, once a promising new drug candidate is designated as a "Breakthrough Therapy", the U.S. Food and Drug Administration (FDA) and sponsor… CONTINUE READING