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                Oncology Center of Excellence

Oncology Center of Excellence

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          Oncology Center of Excellence
          Project EndpointOncology Center of Excellence Project Endpoint
  
  					Advancing the use of endpoints in oncology drug development
	
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              Photo collage of pyramidsPurpose

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.

Goals

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 labelingProject Organization

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

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.

Publications

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

Oncology Center of Excellence
	OCE Project Significant

                                                                                  Content current as of:
      12/06/2023
              
              
Regulated Product(s)
		 Drugs
			  			     			  						              
			
			
			
			
						  OncologyOncology Center of Excellence

          
                        Who We Are - Oncology Center of Excellence
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                        OCE Annual Reports
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