# FDA Oncology Center of Excellence

Source: https://onco.cc/institutions/fda-oce/  
OnCo record `fda-oce` (Institution). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Summary

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.

## Fields

- Kind: Institution
- Last checked: 2026-09-09
- Also known as: OCE; US Food and Drug Administration; FDA
- City: Silver Spring, MD, US
- Type: government
- Website: https://www.fda.gov/about-fda/fda-organization/oncology-center-excellence

## Sources

- Oncology Center of Excellence: https://www.fda.gov/about-fda/fda-organization/oncology-center-excellence
- Hematology/oncology approvals: https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications

## Connected records

- collections: [EMA news and CHMP meeting highlights](https://onco.cc/collections/src-ema-chmp/), [FDA Oncology Approvals (OCE) & Novel Drug Approvals](https://onco.cc/collections/fda-approvals/)
- technologies: [Companion diagnostics](https://onco.cc/technologies/companion-diagnostic/), [MRD / molecular residual disease testing](https://onco.cc/technologies/mrd-testing/)
- institutions: [ACCELERATE](https://onco.cc/institutions/accelerate-platform/), [Agência Nacional de Vigilância Sanitária](https://onco.cc/institutions/anvisa/), [Central Drugs Standard Control Organization](https://onco.cc/institutions/cdsco/), [Clinical Data Interchange Standards Consortium](https://onco.cc/institutions/cdisc/), [Comisión Federal para la Protección contra Riesgos Sanitarios](https://onco.cc/institutions/cofepris/), [European Medicines Agency](https://onco.cc/institutions/ema/), [Health Canada](https://onco.cc/institutions/health-canada/), [International Society for Quality of Life Research](https://onco.cc/institutions/isoqol/), [Medicines and Healthcare products Regulatory Agency](https://onco.cc/institutions/mhra/), [National Cancer Institute (NIH)](https://onco.cc/institutions/nci/), [National Medical Products Administration / Center for Drug Evaluation](https://onco.cc/institutions/nmpa-cde/), [Pharmaceuticals and Medical Devices Agency](https://onco.cc/institutions/pmda/), [Swissmedic](https://onco.cc/institutions/swissmedic/), [Therapeutic Goods Administration](https://onco.cc/institutions/tga/)
- terms: [21st Century Cures Act](https://onco.cc/terms/21st-century-cures-act/), [Accelerated approval](https://onco.cc/terms/accelerated-approval/), [Breakthrough Therapy / Priority Review / Priority Voucher](https://onco.cc/terms/breakthrough-designation/), [Companion diagnostic](https://onco.cc/terms/companion-diagnostic-term/), [Expanded access (compassionate use)](https://onco.cc/terms/expanded-access/), [FDASIA 2012 and the origins of the expedited programmes](https://onco.cc/terms/fdasia-2012/), [FDORA 2022 accelerated approval reforms](https://onco.cc/terms/fdora-2022/), [Federal Food, Drug, and Cosmetic Act and the Kefauver-Harris Amendments](https://onco.cc/terms/fdca/), [ICH good clinical practice (E6)](https://onco.cc/terms/ich-gcp/), [Orphan Drug Act 1983](https://onco.cc/terms/orphan-drug-act/), [Paediatric drug laws: BPCA and PREA](https://onco.cc/terms/bpca-prea/), [RACE for Children Act](https://onco.cc/terms/race-for-children-act/), [Real-world evidence](https://onco.cc/terms/real-world-evidence/), [Right to Try Act 2018 and state right-to-try laws](https://onco.cc/terms/right-to-try/), [Software as a medical device (SaMD)](https://onco.cc/terms/samd/), [Tumour-agnostic (tissue-agnostic) approval](https://onco.cc/terms/tumour-agnostic/)
- people: [R. Angelo de Claro](https://onco.cc/people/r-angelo-de-claro/)
- bottlenecks: [Failures are hidden](https://onco.cc/bottlenecks/b-negative-results/), [Regulatory divergence between regions](https://onco.cc/bottlenecks/b-regulatory-fragmentation/), [Wrong doses](https://onco.cc/bottlenecks/b-dose-optimisation/)
- ideas: [Apply Project Optimus to drugs already on the market](https://onco.cc/ideas/idea-cost-optimus-legacy-drugs/), [Drop the extra switching studies for interchangeable oncology biosimilars](https://onco.cc/ideas/idea-cost-interchangeable-oncology-biosimilars/)
- trials: [ORIENT-11](https://onco.cc/trials/orient-11/)
- roadmaps: [Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation](https://onco.cc/roadmaps/global-access-roadmap/), [Paediatric oncology roadmap: cooperative-group cures → engineered immunity → drugs developed for children first](https://onco.cc/roadmaps/paediatric-oncology-roadmap/), [Trial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on](https://onco.cc/roadmaps/trial-modernisation-roadmap/)

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