FDA's Project Optimus Drives Dose Optimization in Oncology Trials
The FDA's Project Optimus, launched five years ago, remains a focal point in oncology research, as discussed at the AACR 2026 conference. The initiative aims to improve dose selection in early-phase oncology trials by balancing efficacy, safety, and tolerability. Traditional dose-finding methods, which escalate doses until toxicity is intolerable, are being reevaluated in light of new treatment modalities like targeted therapies and immunotherapies. The FDA encourages more structured, comparative evidence generation to support dose selection, emphasizing patient-reported outcomes to better capture tolerability. 
