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.
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.
- Accelerated approval and Project Confirm
- Project Orbis
- Project Optimus (dose optimisation)
- Real-Time Oncology Review
- Oncologic Drugs Advisory Committee
Pages like this
not linked directly; found by shared links- IdeaDrug labels must state which biomarker assays were validated and how they compare
Shares Companion diagnostic, FDA Oncology Approvals (OCE) & Novel Drug Approvals, Companion diagnostics.
- TermOrphan drug
Shares Breakthrough Therapy / Priority Review / Priority Voucher, Tumour-agnostic (tissue-agnostic) approval, Accelerated approval.
- IdeaA reliance pathway for companion diagnostics so the test arrives with the drug
Shares Companion diagnostic, Companion diagnostics, 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, Regulatory divergence between regions.
- IdeaPublish every complete response letter and negative opinion across all regulators
Shares FDA Oncology Approvals (OCE) & Novel Drug Approvals, Failures are hidden, Regulatory divergence between regions.
- IdeaRegulators recognise each other's companion diagnostic approvals
Shares Companion diagnostic, Companion diagnostics, Regulatory divergence between regions.
- TermOff-label
Shares Companion diagnostic, Tumour-agnostic (tissue-agnostic) approval, Accelerated approval.
- IdeaA public registry of cancer treatments that were later shown not to work
Shares FDA Oncology Approvals (OCE) & Novel Drug Approvals, Accelerated approval, Failures are hidden.