Through Project Optimus, the FDA calls for radical changes in the design of early phase trials to identify the optimal doses of oncology drugs to achieve maximal efficacy with better tolerability and patient acceptability. Herein, we discuss approaches that will enable the implementation of this initiative as well as some concerns that the draft guidance has raised in the oncology community.
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The Drug Development Unit is a joint department of the Institute of Cancer Research and The Royal Marsden NHS Foundation Trust. The Institute of Cancer Research has research and commercial interests in licensed drugs such as abiraterone and capivasertib, and classes of drugs such as inhibitors of HSP90, HDAC, PI3K, alpha folate targeted thymidylate synthase, CHK1, MPS-1, GSPT-1 degraders and HSF-1 pathway. The unit receives funding from the Cancer Research UK Convergence Science Centre and the Experimental Cancer Centre and Biomedical Research Centre initiatives. The opinions expressed are personal. U.B. has received honoria for participation in advisory boards from Ellipsis Pharma, PharmEnable, Carrick Therapeutics and Pegasy, has received funding for preclinical research from Avacta and Verastem Oncology and clinical trial funding from Verastem Oncology. S.R. declares no competing interests.
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Rodney, S., Banerji, U. Optimizing the FDA’s Project Optimus: opportunities and challenges. Nat Rev Clin Oncol 21, 165–166 (2024). https://doi.org/10.1038/s41571-023-00853-z
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DOI: https://doi.org/10.1038/s41571-023-00853-z