Five Broad Implications For FDA's Project Optimus: The Future Of Oncology Trials Is Here

By Jason Birri, Mamta Puri-Lechner, Ph.D., and Anna Hertzberg

The FDA's Project Optimus is focused on reforming the dose optimization and selection process in oncology drug development. This is in response to the increasing exposure of patients to oncology drugs for longer periods, due to the advent of targeted therapies. The FDA has released a draft guidance to help sponsors define dosage optimization strategies earlier in the development process.

To prepare for these changes, sponsors are advised to learn from dose optimization in other therapeutic areas, become experts on their product's dosing decisions, and discuss dose-range findings early in the development process. The FDA is emphasizing the importance of thoughtful design and dose optimization in oncology drug development.

Halloran's continuing analysis of the dose-optimization landscape over the last years leads us to five common themes they believe will help sponsors prepare for these changes. Access them by reading the article below.