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Embracing Project Optimus: Can we Leverage Evolutionary Theory to Optimize Dosing in Oncology?
Timothy Qi1, Tyler Dunlap1, Yanguang Cao2,3
1Division of Pharmacotherapy and Experimental Therapeutics, Eshelman School of Pharmacy, The University of North Carolina at Chapel Hill, 301 Pharmacy Ln, Chapel Hill, NC, 27599, USA.
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.
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