Project Optimus, an initiative led by the U.S. Food and Drug Administration’s (FDA) Oncology Center of Excellence (OCE), aims to transform the way oncology drugs are developed and dosed. Its primary objectives include improving patient outcomes and minimizing toxicity.
Pharmacometrics, a critical component of Project Optimus, involves quantitative modeling and simulation to understand drug behavior. By integrating pharmacokinetics (PK) and pharmacodynamics (PD), pharmacometrics guides dose selection, optimizing treatment regimens for both efficacy and safety. Project Optimus leverages pharmacometrics to enhance oncology drug development and benefit patients.
Project Optimus has led to the optimization of several drugs in the field of oncology. Here are some specific examples:
Sotorasib (Lumakras):
Sotorasib, a KRAS G12C inhibitor, received post-approval dose adjustments to enhance safety and tolerability.2
Capecitabine (Xeloda):
Capecitabine, an oral chemotherapy drug, underwent dose optimization to improve its therapeutic benefit while minimizing toxicity.2
Lenvatinib (Lenvima):
Lenvatinib, a tyrosine kinase inhibitor, also benefited from dose adjustments to achieve a balance between efficacy and safety.2
These examples demonstrate how Project Optimus has influenced drug development by refining dosing strategies and ensuring better outcomes for patients.
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Interested parties wanting more information on the impact pharmacometrics is having on Project Optimus may contact us at information@momentummetrix.com.
U.S. Food and Drug Administration. (2023). Project Optimus: Transforming Oncology Drug Development. https://www.fda.gov/drugs/oncology-drugs/project-optimus-transforming-oncology-drug-development
Rodney, S, & Banerji, U. (2024) “Optimizing the FDA’s Project Optimus: Opportunities and Challenges.” Nature Reviews Clinical Oncology, 21, 165-166. https://www.nature.com/articles/s41571-023-00853-z