In 2024, the US FDA approved several new agents for the treatment of patients with cancer, including small-molecule inhibitors, immune-checkpoint inhibitors, bispecific antibodies, antibody–drug conjugates and cell and gene therapy products. Areas of regulatory focus included the accelerated approval programme and diligent completion of post-marketing trials, convening of Oncologic Drugs Advisory Committee meetings to ensure transparent discussions of complex regulatory issues, and continuation of robust, meaningful engagement with the oncology community to foster efficient drug development.
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Acknowledgements
The authors would like to acknowledge the following individuals at the US FDA: K. Barnett and U. Mahat as well as their leadership L. Fashoyin-Aje and A. Das (Office of Clinical Evaluation in the Center for Biologics Evaluation and Research) for assistance with additional information on the complex biologics approvals; R. Pazdur, M. Theoret and T. Kim (leadership at the Oncology Center of Excellence and Office of Oncologic Diseases); L. Amiri-Kordestani, S. Lemery, E. Larkins, A. De Claro and N. Gormley (Division Directors in the Office of Oncologic Diseases); and the many multidisciplinary scientific review staff across the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research. Finally, we acknowledge and thank the clinical investigators, research staff and patients who participated in the clinical trials that led to these approvals.
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Agrawal, S., Park, E. & Kluetz, P.G. FDA approvals in 2024: new options for patients across cancer types and therapeutic classes. Nat Rev Clin Oncol 22, 457–458 (2025). https://doi.org/10.1038/s41571-025-01018-w
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DOI: https://doi.org/10.1038/s41571-025-01018-w
