In 2023, the US FDA approved several new cancer drugs and biologic agents, including seven small-molecule inhibitors, four bispecific T cell engagers, two anti-PD-1 antibodies and one cell therapy product. Regulatory focus areas included analyses of biomarker-positive subgroups that drive efficacy, equipoise in randomized controlled trials and a new authority to require confirmatory trials be underway before accelerated approval.
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The authors thank P. Kluetz and M. Theoret (both of the US FDA) for their assistance with writing this manuscript.
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Norsworthy, K.J., Lee-Alonzo, R.J. & Pazdur, R. FDA approvals in 2023: biomarker-positive subsets, equipoise and verification of benefit. Nat Rev Clin Oncol 21, 333–334 (2024). https://doi.org/10.1038/s41571-024-00871-5
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DOI: https://doi.org/10.1038/s41571-024-00871-5
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