OCE Cancer in Older Adults Program
Improving outcomes for older adults with cancer through engagement and research
Purpose
The Cancer in Older Adults Program is a public health initiative established by the FDA Oncology Center of Excellence (OCE) in 2024 to improve outcomes for older adults with cancer through research and engagement. This program serves as a resource for clinicians and scientists, and a focal point for enhancing engagement across FDA’s oncology divisions with external stakeholders.
The Cancer in Older Adults Program builds on OCE’s Project Silver, begun in 2020, that focuses on increasing representation of older adults (65 years and older) in cancer clinical trials.
Goals
Engagement
- Engage with patient advocacy groups to assess opportunities to:
- Advance treatment goals important to older adults with cancer
- Foster clinical trial enrollment
- Interact with global regulatory agencies and other key oncology stakeholders including professional organizations to identify opportunities to improve outcomes for older adults with cancer.
Science and Research
- Educate FDA staff to develop and to maintain expertise in geriatric oncology.
- Evaluate geriatric assessment tools and other measures for physiologic age
- Examine regulatory submissions for data in age subgroups
- Assess the need for additional data post approval.
- Collaborate with external and internal stakeholders across scientific disciplines and groups—clinicians, pharmacologists, toxicologists, social scientists, statisticians, patient advocates—to foster geriatric oncology regulatory science research
Regulatory Policy
- Encourage sponsors to conduct inclusive and representative trials early in development
- Guidance development
Meet the Team
Project Lead: Bindu Kanapuru, MD, Associate Director for Cancer in Older Adults, Oncology Center of Excellence; and Supervisory Associate Director of Therapeutic Review, Division of Hematological Malignancies II, Office of Oncologic Diseases, Center for Drug Evaluation and Research
Project Management: Pamela Balcazar, MS, Health Scientist, Oncology Center of Excellence
Select Events
FDA has sponsored multiple public workshops to further engage with the stakeholders and the broader community on the importance of diverse representation in cancer clinical trials.
- November 6, 2017: FDA-ASCO Public Workshop: Geriatric Oncology Workshop
- January 22-27, 2021: Improving the Evidence Base for Treatment Decision Making for Older Adults with Cancer - National Academies Workshop
- March 23, 2021: Roadmap to 2030 for New Drug Evaluation in Older Adults
FDA Guidance Documents
- Inclusion of Older Adults in Cancer Clinical Trials
- Guideline for the Study of Drugs Likely to be Used in the Elderly
- E7 Studies in Support of Special Populations; Geriatrics; Questions and Answers
- Studies in Support of Special Populations: Geriatrics ICH-E7
- Geriatric Information in Human Prescription Drug and Biological Product Labeling
Select Publications
- Improving the Evidence Base for Treatment Decision Making for Older Adults with Cancer: Proceedings of a Workshop—In Brief. The National Academies Press.
- Levit LA, Singh H, Klepin HD, Hurria A. Expanding the Evidence Base in Geriatric Oncology: Action Items From an FDA-ASCO Workshop. J Natl Cancer Inst. 2018 Nov 1;110(11):1163-1170.
- Kanapuru B, Singh H, Kwitkowski V, Blumenthal G, Farrell AT, Pazdur R. Older adults in hematologic malignancy trials: Representation, barriers to participation and strategies for addressing underrepresentation. Blood Rev. 2020 Sep;43:100670.