White Paper

The Shifting Paradigm Of Dose Selection In Oncology

By Jeffrey Keefer, MD, PhD, Vice President and Head of Hematology/Oncology Center of Excellence, IQVIA; David Alsadius, MD, PhD, Senior Medical Director for the Oncology Center of Excellence, IQVIA; Jeffrey Hodge, Vice President of Precision Medicine in the Oncology Center of Excellence, IQVIA; and Matthew Simmons, Global Head of Oncology Strategy, IQVIA Biotech

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The landscape of oncology drug development is undergoing a significant transformation, moving away from the traditional approach of dose selection. Molecularly targeted, immune-based, and cell-based therapies frequently lack proper characterization of doses and schedules during registrational trials, leading to inefficiencies in the overall process. As a result, the industry and regulators have launched new efforts to reevaluate the maximum tolerated dose, which often burdens patients and results in excessive toxicity.

Specifically, in January 2023, the FDA's Oncology Center of Excellence announced the start of Project Optimus and the publication of a draft guidance to revolutionize dose selection and maximize patient outcomes by shifting from a drug-centered to a patient-centered approach to drug development.

In this insight brief, authors explore strategies for integrating dose finding and optimization into early clinical development. This enables a sophisticated analysis of dose and schedule before progressing into later phase trials. Additionally, the implications of this new paradigm for sponsors developing oncology drugs are highlighted, shedding light on the evolving drug development landscape for cancer patients.

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