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  1. Oncology Center of Excellence

Project Endpoint

Advancing the use of endpoints in oncology drug development

Project Endpoint Graphic Element 2024


The Oncology Center of Excellence (OCE) Project Endpoint, begun in 2022, aims to enhance the development of endpoints in oncology drug development and foster engagement with the broader community to advance our understanding of and explore potential uses for early, novel endpoints. Considering the complementary nature of early endpoints and late endpoints, such as overall survival, Project Endpoint also aims to advance the use of more established late endpoints.


Project Endpoint aims to develop and provide: 

  • Cross-divisional and cross-center consistency 
  • Coordination of early endpoint efforts within oncology
  • External engagement with stakeholders
  • Education on latest advancements
  • Standardized assessment of early endpoint data in applications
  • Standardized reporting of early endpoint results in labeling

Project Organization

Project Endpoint is led by Nicole Gormley, MD, Director, Division of Hematologic Malignancies II, Office of Oncologic Diseases, CDER, and Associate Director of Endpoint Development in the Oncology Center of Excellence, FDA.

Experts from across the OOD divisions, CDRH and CBER, as well as FDA experts in statistics and labeling take part in regular meetings. 

The Project Endpoint participants also participate in meetings and workshops with external stakeholders including the International Myeloma Society, Friends of Cancer Research, and Foundation for the NIH Biomarkers Consortium. 

News and Events 

July 18, 2023: FDA-AACR-ASA Workshop: Overall Survival in Oncology Clinical Trials.


Irreconcilable Differences: The Divorce Between Response Rates, Progression-Free Survival, and Overall Survival. Merino M, Kasamon Y, Theoret M, Pazdur R, Kluetz P, Gormley N. J Clin Oncol. 2023 Mar 17;JCO2300225. doi: 10.1200/JCO.23.00225.

Minimal Residual Disease Data in Hematologic Malignancy Drug Applications and Labeling: An FDA Perspective. Baines AC, Yazdy MS, Kasamon YL, Ershler R, Jen EY, Kanapuru B, Richardson NC, Lane A, Carioti T, Theoret MR, Pazdur R, Gormley NJ.Clin Cancer Res. 2023 Aug 1;29(15):2748-2752. doi: 10.1158/1078-0432.CCR-22-3579.PMID: 36892497

Further Information

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