In 2022, the FDA approved numerous new drug and biologic agents, including targeted small molecules, immunotherapeutics, a gene therapy and a radiopharmaceutical. Several drug development challenges were also addressed, and key focus areas for the FDA Oncology Center of Excellence included ongoing monitoring of the Accelerated Approval programme and drug dose optimization.
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The authors thank P. Kluetz and M. Theoret (both based at the US FDA) for their assistance with writing this manuscript.
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Telaraja, D., Gormley, N. & Pazdur, R. Approvals in 2022: overall survival, dose optimization, new approvals and beyond. Nat Rev Clin Oncol 20, 207–208 (2023). https://doi.org/10.1038/s41571-023-00741-6
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DOI: https://doi.org/10.1038/s41571-023-00741-6