Optimizing the FDA's Project Optimus: opportunities and challenges

Affiliations

¹ Drug Development Unit, The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, UK. simon.rodney@icr.ac.uk.
² Drug Development Unit, The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, UK. udai.banerji@icr.ac.uk.

Simon Rodney et al. Nat Rev Clin Oncol. 2024 Mar.

. 2024 Mar;21(3):165-166.

doi: 10.1038/s41571-023-00853-z.

¹ Drug Development Unit, The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, UK. simon.rodney@icr.ac.uk.
² Drug Development Unit, The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust, London, UK. udai.banerji@icr.ac.uk.

No abstract available

References

1. FDA. Optimizing the dosage of human prescription drugs and biological products for the treatment of oncologic diseases. fda.gov, https://www.fda.gov/regulatory-information/search-fda-guidance-documents... (FDA, 2023).
1. Roda, D., Jimenez, B. & Banerji, U. Are doses and schedules of small-molecule targeted anticancer drugs recommended by phase I studies realistic? Clin. Cancer Res. 22, 2127–2132 (2016). - DOI - PubMed
1. Hong, D. S. et al. KRAS^G12C inhibition with sotorasib in advanced solid tumors. N. Engl. J. Med. 383, 1207–1217 (2020). - DOI - PubMed - PMC
1. Hennessy, B. T., Gauthier, A. M., Michaud, L. B., Hortobagyi, G. & Valero, V. Lower dose capecitabine has a more favorable therapeutic index in metastatic breast cancer: retrospective analysis of patients treated at M. D. Anderson Cancer Center and a review of capecitabine toxicity in the literature. Ann. Oncol. 16, 1289–1296 (2005). - DOI - PubMed
1. Brose, M. S. et al. A randomized study of lenvatinib 18 mg vs 24 mg in patients with radioiodine-refractory differentiated thyroid cancer. J. Clin. Endocrinol. Metab. 107, 776–787 (2022). - DOI - PubMed