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  1. OCE Annual Reports

2023 OCE Annual Report

OCE AR 2023

Center Director's Message

From the time I first joined the FDA in 1999 through the beginning of the Oncology Center of Excellence in 2017 and continuing today, I’ve strongly believed that our work to advance the development and regulation of oncology products must put patients with cancer front and center in our programs and projects. In 2023, the three new OCE projects highlighted patient-centric approaches to achieving better outcomes for patients with cancer.

  • Project ASIATICA is bringing together advocacy, research, and policy regarding Asian American, Native Hawaiian, and other Pacific Islander patients with cancer.
  • Project Endpoint is working 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 that will ultimately improve outcomes for patients. 
  • Project Pragmatica provided feedback and interaction with the National Cancer Institute to develop the Pragmatica-Lung Study, a randomized phase 3 trial of a two-drug combination in lung cancer, launched in April 2023. The trial encourages streamlined eligibility criteria and safety data collection, and specific community recruitment efforts aimed at inclusive populations. 

OCE has over 30 ongoing programs and projects that work daily to achieve patient-centric approaches to oncology product development. Some notable examples of progress from this past year include:

  • Project Equity published a report on the first year of its experience reviewing Diversity Action Plans that drug developers began submitting to address diversity and inclusion in clinical trials, in response to an FDA draft guidance led by OCE. 
  • The Patient-Focused Drug Development Program sustained its mission of incorporating patient experience data, including patient-reported symptoms and function, into oncology drug development and regulatory decision making.
  • The Oncology Real World Evidence Program is working to advance the use of RWE in oncology drug development through involvement in several Oncologic Drugs Advisory Committee meetings, various FDA guidance working groups, and RWE initiatives. The project has 30 ongoing scientific collaborations with various collaborators.

In 2023, the OCE facilitated 83 oncology therapeutic product approvals, 14 of which were new medical entities or new biological license applications. Significantly, there were 11 approvals of 7 different drugs and biologics to treat children with cancer. In addition, 118 oncology devices were authorized.

Please explore our 2023 Annual Report to learn more about the OCE’s work. I hope you will be inspired to take part in our programs and projects to improve the lives of patients with cancer.

Richard Pazdur, M.D.
Director, Oncology Center of Excellence


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