Summary:
Project Optimus is an initiative to reform the dosage optimization and dosage selection paradigm in oncology drug development. New approaches to optimize dosages of oncology drugs 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 2023, FDA Office of Clinical Pharmacology and ISoP co-sponsored the workshop discussing best practices and methods to incorporate quantitative methods to improve dosage optimization in the context of intrinsic and extrinsic factors for oncology drug development. The purpose of this program is to educate about the importance of dosage optimization for oncology drugs during clinical development from which patients will benefit. Previously, the Model Informed Drug Development (MIDD) for Oncology Products Workshop in 2018 focused 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.