Loading
institutionsInstitution
FDA Oncology Center of Excellence
The US regulator's oncology hub, which approves cancer drugs, runs accelerated approval and Project Orbis, and is pushing better dose-finding through Project Optimus.
Also called: OCEUS Food and Drug AdministrationFDA
Overview
Created in 2017 under the 21st Century Cures Act and led from its founding by Richard Pazdur, the Oncology Center of Excellence coordinates cancer drug, biologic and device review across FDA centres. Its programmes include Real-Time Oncology Review, Assessment Aid, Project Orbis (concurrent review with Australia, Canada, the UK, Switzerland, Singapore, Brazil and Israel), Project Optimus (dose optimisation before approval), Project FrontRunner (testing new drugs earlier in the disease course), Project Facilitate for expanded access, and Project Confirm, which tracks accelerated approvals and their confirmatory trials. The OCE has led guidance on tissue-agnostic approvals, ctDNA and MRD as endpoints, and patient-reported outcomes, and its Oncologic Drugs Advisory Committee is the public forum where contested approvals are debated.
Location
Silver Spring, MD, US
Type
government
Newsweek 2026 oncology rank
Not in top 300 listing used
OnCo score
#42 · 58 points (0 Newsweek + 0 NCI + 58 from 29 linked objects) · ranking
- Accelerated approval and Project Confirm
- Project Orbis
- Project Optimus (dose optimisation)
- Real-Time Oncology Review
- Oncologic Drugs Advisory Committee
Similar pages
- TermOrphan drug
Shares Orphan Drug Act 1983, Breakthrough Therapy / Priority Review / Priority Voucher, RACE for Children Act, Accelerated approval.
- TermAbigail Alliance v. von Eschenbach (2007)
Shares Right to Try Act 2018 and state right-to-try laws, Expanded access (compassionate use), Federal Food, Drug, and Cosmetic Act and the Kefauver-Harris Amendments, Accelerated approval.
- TermProject Orbis
Shares R. Angelo de Claro, ICH good clinical practice (E6), Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on, Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation.
- TermChina Drug Administration Law (2019) and expedited pathways
Shares Breakthrough Therapy / Priority Review / Priority Voucher, ICH good clinical practice (E6), National Medical Products Administration / Center for Drug Evaluation, Accelerated approval.
- TermFast Track and RMAT designations
Shares 21st Century Cures Act, FDASIA 2012 and the origins of the expedited programmes, Breakthrough Therapy / Priority Review / Priority Voucher, Accelerated approval.
- TermSakigake designation (Japan)
Shares Pharmaceuticals and Medical Devices Agency, Breakthrough Therapy / Priority Review / Priority Voucher, Accelerated approval, Regulatory divergence between regions.
- TermJapan conditional early approval and time-limited approval
Shares Pharmaceuticals and Medical Devices Agency, FDORA 2022 accelerated approval reforms, Accelerated approval, Regulatory divergence between regions.
- IdeaConditional approvals that lapse automatically if the confirmatory trial is late
Shares FDA Oncology Approvals (OCE) & Novel Drug Approvals, Accelerated approval, Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on, Regulatory divergence between regions.
technologies
institutions
ACCELERATEAgência Nacional de Vigilância SanitáriaCentral Drugs Standard Control OrganizationClinical Data Interchange Standards ConsortiumComisión Federal para la Protección contra Riesgos SanitariosEuropean Medicines AgencyHealth CanadaInternational Society for Quality of Life ResearchMedicines and Healthcare products Regulatory AgencyNational Cancer Institute (NIH)National Medical Products Administration / Center for Drug EvaluationPharmaceuticals and Medical Devices AgencySwissmedicTherapeutic Goods Administration
terms
21st Century Cures ActAccelerated approvalBreakthrough Therapy / Priority Review / Priority VoucherCompanion diagnosticExpanded access (compassionate use)FDASIA 2012 and the origins of the expedited programmesFDORA 2022 accelerated approval reformsFederal Food, Drug, and Cosmetic Act and the Kefauver-Harris AmendmentsICH good clinical practice (E6)Orphan Drug Act 1983Paediatric drug laws: BPCA and PREARACE for Children ActReal-world evidenceRight to Try Act 2018 and state right-to-try lawsSoftware as a medical device (SaMD)Tumour-agnostic (tissue-agnostic) approval
trials
roadmaps
Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovationPaediatric oncology roadmap: cooperative-group cures → engineered immunity → drugs developed for children firstTrial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on