Embracing Project Optimus: Can we Leverage Evolutionary Theory to Optimize Dosing in Oncology?

ABSTRACT: Project Optimus is a US Food and Drug Administration (FDA) initiative to reform dose selection in oncology drug development. Here, we focus on tumor evolution, a broadly observed phenomenon that invariably leads to therapeutic failure and disease relapse, and its effect on the exposure-response (E-R) relationships of oncology drugs. We propose a greater emphasis on tumor evolution during clinical development to facilitate the selection of optimal doses for molecularly targeted therapies and immunotherapies in oncology.

SUBMITTER: Qi T 

PROVIDER: S-EPMC9789176 | biostudies-literature | 2022 Dec

REPOSITORIES: biostudies-literature