Read the latest white paper by the IDDI experts
In January 2023, the Food and Drug Administration (FDA) released the draft guidance outlining the key principles of Project Optimus, whose overarching goal is to educate, innovate, and collaborate with all relevant stakeholders to move forward with a dose-finding and dose-optimization paradigm in oncology in a manner that maximizes the relationship between efficacy, safety and tolerability of novel agents. In August 2024, a final guidance was published, taking the comments by various stakeholders into account.
In the current article, we summarize key principles and the relevant literature on dose optimization in oncology, also providing our views on the implementation of Project Optimus by biotechnology and pharmaceutical sponsors.