All Times EDT
Keywords: Dose, dosage, optimization
The current dosing paradigm for oncology drugs was developed for cytotoxic chemotherapies and focuses on the maximum tolerated dose (MTD). However, most current oncology drugs in development are targeted therapies, including kinase inhibitors and monoclonal antibodies. This talk will identify why the current dosing paradigm for oncology drugs is not suited for the development of non-cytotoxic agents. The talk will describe FDA Oncology Center of Excellence’s Project Optimus, including the impetus for its formation and its goals. The talk will highlight key components of a successful dose optimization strategy which include: sufficient characterization of pharmacokinetics, incorporation of pharmacodynamic endpoints, evaluation of dose and exposure- response relationships, and use of randomized dose trials. Case examples will be incorporated to illustrate important concepts. At the end of the talk, participants will understand why dose optimization is an essential component of developing safe and effective oncology drugs and understand key principles for design and implementation of a successful plan for dose optimization.