The Oncology Center of Excellence (OCE) Project Optimus is an initiative to reform the dose optimization and dose selection paradigm in oncology drug development. New approaches to optimize doses of targeted anticancer agents are needed. FDA continues to strongly advocate for a paradigm shift that moves from identifying the maximum tolerated dose determined based on initial safety assessments to that of identifying dosage(s) based on relevant available information, including pharmacokinetic, pharmacodynamic, safety, tolerability, activity, and other factors. Quantitative methods can effectively leverage this information to support dosage selection for clinical trials and ultimately, labeling, and clinical practice.
In 2018, the FDA and ISoP conducted a public workshop focusing on best practices of using model-informed approaches to integrate pharmacokinetics, pharmacodynamics, efficacy, and safety data to inform oncology drug development and this workshop initiated broader discussion regarding how to use model-based approaches to support dosage selection. In the 2023 workshops, the FDA and ISoP discussed best practices and methods to incorporate quantitative methods to improve dose optimization in the context of intrinsic and extrinsic factors as well as in the context of new disease and combination settings for oncology drug development.