As oncology therapeutics evolve beyond cytotoxic agents towards targeted therapies and novel mechanisms, the traditional approach of identifying the maximum tolerated dose (MTD) may not adequately optimize dosing. The FDA's Project Optimus initiative aims to reform dose optimization strategies, providing guidance on more comprehensive, patient-centric dose selection for innovative oncology drugs.
Key takeaways
- Project Optimus encourages leveraging pharmacokinetic, pharmacodynamic, and early clinical data to guide dose selection, rather than solely relying on maximum tolerated dose.
- The initiative recommends evaluating multiple doses or schedules in randomized trials, preventing excessive patient exposure to potentially suboptimal or overly toxic doses.
- Early dialogue with the FDA through pre-IND meetings allows tailored advice on optimal dose-finding strategies for each investigational product.
- Project Optimus represents a shift towards more comprehensive dose optimization, aligning with the evolving landscape of innovative oncology therapeutics.
To learn more about overcoming translational challenges in moving drug candidates from preclinical to clinical stages, read the full article.
