Food and Drug Administration Oncology Center of Excellence

Food and Drug Administration Oncology Center of Excellence
Name	Oncology Center of Excellence
Formation	2017
Headquarters	Silver Spring, Maryland
Parent organization	Food and Drug Administration
Leader title	Director

Food and Drug Administration Oncology Center of Excellence

The Oncology Center of Excellence (OCE) is an integrated program within the Food and Drug Administration created to coordinate regulatory review, policy, and outreach for oncology products, combining expertise across Center for Drug Evaluation and Research, Center for Biologics Evaluation and Research, and Center for Devices and Radiological Health. It serves as a focal point for interactions with stakeholders including National Cancer Institute, American Society of Clinical Oncology, European Medicines Agency, World Health Organization, and industry groups such as Pharmaceutical Research and Manufacturers of America, facilitating expedited pathways that connect to statutes like the 21st Century Cures Act and regulatory precedents involving Accelerated approval and Breakthrough therapy designation.

Overview

The OCE functions as a cross-center initiative aligning review pathways across divisions responsible for small molecules, biologics, and devices, integrating experience from institutions like Mayo Clinic, Memorial Sloan Kettering Cancer Center, Dana-Farber Cancer Institute, Johns Hopkins Hospital, and Fred Hutchinson Cancer Research Center. It synthesizes policies influenced by regulatory frameworks exemplified by Orphan Drug Act, Food, Drug, and Cosmetic Act, Prescription Drug User Fee Act, and harmonization efforts with the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. Stakeholders include advocacy organizations such as American Cancer Society and professional societies such as Society for Immunotherapy of Cancer and European Society for Medical Oncology.

History and Establishment

The OCE was established in 2017 under the leadership of FDA commissioners and senior officials informed by precedent regulatory responses to innovations like CAR T-cell therapy, checkpoint inhibitors, and precision oncology exemplified by trastuzumab and imatinib. Its founding followed high-profile interactions among the FDA, lawmakers in the United States Congress, and researchers from National Institutes of Health and NCI-MATCH trials, responding to advances seen at conferences such as ASCO Annual Meeting and European Society for Medical Oncology Congress. Historical drivers included regulatory cases involving pembrolizumab, nivolumab, and complex device-drug combinations like those reviewed under combinations similar to HER2-targeted therapies and diagnostic partnerships akin to FoundationOne CDx.

Mission and Organizational Structure

OCE's mission emphasizes coordinated review, science-driven policy, and stakeholder engagement across review programs from Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research to Center for Devices and Radiological Health. Leadership comprises directors and scientific leads with backgrounds tied to institutions such as Harvard Medical School, Stanford University School of Medicine, University of Pennsylvania Perelman School of Medicine, and University of California, San Francisco. Organizational units interface with programs including Project Orbis, international collaborations with Health Canada, Therapeutic Goods Administration, and advisory structures akin to panels convened by the Oncologic Drugs Advisory Committee and collaborations with National Comprehensive Cancer Network.

Regulatory Activities and Initiatives

The OCE coordinates expedited development and review mechanisms including Breakthrough therapy designation, Priority review, and Accelerated approval, applying standards shaped by precedents from approvals of agents like sorafenib, erlotinib, and immunotherapies such as ipilimumab. It operates pilot programs and initiatives such as real-world evidence efforts that draw on data sources like Surveillance, Epidemiology, and End Results Program and claims datasets used by agencies including Centers for Medicare & Medicaid Services. OCE leads cross-cutting programs such as Project Facilitate-style communication platforms, supports digital health evaluations comparable to work with FDA's Digital Health Unit, and engages in international regulatory harmonization through forums like International Coalition of Medicines Regulatory Authorities.

Research, Collaboration, and Partnerships

OCE fosters collaborative research partnerships with academic centers including MD Anderson Cancer Center and research networks such as Clinical Trials Transformation Initiative and Alliance for Clinical Trials in Oncology, and cooperates with funders such as National Cancer Institute and private consortia like Project Data Sphere. It has sponsored public workshops and guidance development with stakeholders like American Association for Cancer Research, patient advocacy groups such as Livestrong Foundation, and diagnostic developers exemplified by Roche and Illumina. Internationally, OCE engages with counterparts including European Medicines Agency, Therapeutic Goods Administration of Australia, and regulators from Japan Pharmaceuticals and Medical Devices Agency to align on topics such as companion diagnostics and biomarker-driven trials like basket trials and umbrella trials.

Impact and Key Achievements

OCE has influenced regulatory decisions on novel modalities including cellular therapies represented by tisagenlecleucel and engineered constructs similar to CAR T products, advanced policies on use of real-world evidence in oncology reflecting cases such as label expansions for established agents, and supported coordinated international reviews through Project Orbis partnerships with agencies like Health Canada and Australian Therapeutic Goods Administration. It has produced guidance and educational outputs used by stakeholders at conferences like ASCO and publications in journals such as The New England Journal of Medicine and Journal of Clinical Oncology, and has contributed to expedited patient access pathways shaped by interactions with Centers for Medicare & Medicaid Services reimbursement policies. OCE's work continues to shape evaluation frameworks for next-generation therapies from companies including Novartis, Bristol Myers Squibb, Merck & Co., and collaborative research platforms like Cancer Research UK.

Category:United States Food and Drug Administration