Project Optimus explained: what the FDA expects on oncology dosing
The US Food and Drug Administration's Oncology Center of Excellence (OCE) launched Project Optimus in 2021 as an initiative to reform how doses and schedules are selected in cancer drug development. The supporting guidance for industry, Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases, was published in August 2024 after a draft issued in January 2023.
Five years in, the direction of travel is settled but the practice is not. At an educational session at the American Association for Cancer Research (AACR) annual meeting in San Diego on April 18 2026, the FDA's Mirat Shah described changes in development strategies since launch alongside continued variability in how sponsors interpret the agency's expectations. For developers, the commercial consequence is that dose work, and its cost, moves earlier.
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