IDDI Webinar: Navigating FDA Expectation for Drug Approval

ABSTRACT

The Oncology Center of Excellence (OCE) initiative, Project Optimus and its related FDA Draft Guidance emphasize the shift from finding the maximum tolerated dose to the biological optimal dose for non-cytotoxic oncology therapeutic products.

This approach requires more data, and oncology drug developers will need to focus on meeting expectations for dose optimization prior to achieving drug approval.

Randomization to different doses is key and allows for dose optimization in a registrational Phase 2/3 trial, potentially with the aim of accelerated approval.

KEY TAKEWAYS

An overview of important aspects of Project Optimus and accelerated approval with a focus on statistical methods and adaptive trials, including model‑based and model-assisted dose escalation designs, adaptive designs for dropping a dose arm at interim, and

Phase 2/3 trials testing both an early and late endpoint for accelerated and full approval, respectively.

The role of group sequential designs and sample size reassessment when designing registrational trials without good information on treatment effectiveness

FOLLOW US FOR MORE: www.iddi.com