All Times EDT
Keywords: dose, optimization, oncology
The dose selection strategy in oncology has traditionally focused on identifying the maximum tolerated dose with an emphasis on dose limiting toxicities. However, in the era of targeted therapies, long-term tolerability is of great importance and dose-response relationships support moving away from this “more is better” approach. This presentation will give an overview of FDA/OCE’s Project Optimus, provide regulatory perspectives on the importance of dose optimization, and discuss design elements for an updated dose selection strategy to optimize dose selection and enable a more complete understanding of the relationship between drug exposure and clinical outcomes.