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.
This is a preview of subscription content, access via your institution
Access options
Access Nature and 54 other Nature Portfolio journals
Get Nature+, our best-value online-access subscription
$29.99 / 30 days
cancel any time
Subscribe to this journal
Receive 12 print issues and online access
$209.00 per year
only $17.42 per issue
Buy this article
- Purchase on Springer Link
- Instant access to full article PDF
Prices may be subject to local taxes which are calculated during checkout
References
FDA. Oncologic Drugs Advisory Committee (ODAC) meeting. fda.gov, https://www.fda.gov/advisory-committees/advisory-committee-calendar/april-28-2023-meeting-oncologic-drugs-advisory-committee-meeting-announcement-04282023 (28 April 2023).
FDA. Oncology Drugs Advisory Committee (ODAC) meeting. fda.gov, https://www.fda.gov/advisory-committees/advisory-committee-calendar/november-16-2023-meeting-oncologic-drugs-advisory-committee-meeting-announcement-11162023 (16 November 2023).
FDA. Oncologic Drugs Advisory Committee (ODAC) meeting. fda.gov, https://www.fda.gov/media/172696/download (5 October 2023).
Amgen. Amgen provides regulatory update on status on Lumakras (sotorasib). Amgen, https://www.amgen.com/newsroom/press-releases/2023/12/amgen-provides-regulatory-update-on-status-of-lumakras-sotorasib (26 December 2023).
FDA. Project Optimus. fda.gov, https://www.fda.gov/about-fda/oncology-center-excellence/project-optimus (accessed 30 January 2024).
FDA. Project Pragmatica. fda.gov, https://www.fda.gov/about-fda/oncology-center-excellence/project-pragmatica (accessed 30 January 2024).
Jungmeyer, E. Pragmatic approach to trial design born from Lung-MAP substudy. ilcn.org, https://www.ilcn.org/pragmatic-approach-to-trial-design-born-from-lung-map-substudy/ (21 March 2023).
FDA. Project Equity. fda.gov, https://www.fda.gov/about-fda/oncology-center-excellence/project-equity (accessed 30 January 2024).
FDA. Project Endpoint. https://www.fda.gov/about-fda/oncology-center-excellence/project-endpoint#:~:Text=The%20Oncology%20Center%20of%20Excellence,uses%20for%20early%2C%20novel%20endpoints (accessed 30 January 2024).
AACR. FDA-AACR-ASA Workshop: Overall Survival in Oncology Clinical Trials. aacr.org, https://www.aacr.org/professionals/policy-and-advocacy/regulatory-science-and-policy/events/fda-aacr-asa-workshop-overall-survival-in-oncology-clinical-trials/ (18 July 2023).
Acknowledgements
The authors thank P. Kluetz and M. Theoret (both of the US FDA) for their assistance with writing this manuscript.
Author information
Authors and Affiliations
Corresponding author
Ethics declarations
Competing interests
The authors declare no competing interests.
Supplementary information
Rights and permissions
About this article
Cite this article
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
Published:
Issue Date:
DOI: https://doi.org/10.1038/s41571-024-00871-5