Dose Optimization in Oncology Drug Development: Risk Factors for Postmarketing Requirements and Commitments.

ABSTRACT: Optimal dosing of oncological drugs is historically determined based on the "higher is better" paradigm. However, a paradigm shift in optimal dose selection has occurred in the development of new modalities, including molecularly targeted drugs, antibody drugs, and immunotherapies. In 2021, Project Optimus was launched by the Food and Drug Administration Oncology Center of Excellence to reform the dose optimization and dose selection paradigm in oncology drug development. In August 2024, "Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases" was published, encouraging randomized evaluation of the benefit/risk profile of a range of doses before initiating a registration trial. Although Project Optimus offers general guidance on do

SUBMITTER: Kitagaki H 

PROVIDER: S-EPMC12439010 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature