Project Optimus: FDA Effort on Oncology Dose Optimization

Elizabeth G. Gibson, Pharm.D., Ph.D. 

Oncology dose optimization is a critical aspect of cancer treatment. The objective is to provide the patient with the right amount of medication to effectively treat their cancer while minimizing the risk of harmful side effects. This is essential as it can have a significant impact on the overall prognosis and quality of life of the patient. Dose-finding trials in oncology have historically been designed to find the maximum-tolerated dose (MTD). This strategy was utilized for cytotoxic chemotherapy drugs that had steep dose-response curves, limited target specificity, and the attitude from physicians and patients to accept toxicity to treat a deadly cancer.