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FDA Oncology Approvals (OCE) & Novel Drug Approvals
The FDA's oncology approval notifications are the official record of what is approved for what.
Overview
The FDA's oncology approval notifications are the official record of what is approved for which indication, and this collection holds every oncology approval notification and label together with the FDA's annual list of first-time drug approvals. It is maintained by the US FDA Oncology Center of Excellence and is public domain. OnCo also links the AACR quarterly digests of oncology approvals, and the notifications are best read alongside Project Orbis for international concurrent review. On OnCo the record is cited by bottlenecks including Trial design, endpoints and cost, Wrong doses, Regulatory divergence between regions, Prices and value and Toxicity and quality of life are undervalued, and by the idea Require every oncology candidate to publish how much reaches the brain.
Holds
Every oncology approval notification, label, and the annual novel drug list.
Licence
Public domain
Maintainer
US FDA Oncology Center of Excellence
Similar pages
- RoadmapTrial modernisation roadmap: the randomised trial → platforms and adaptive designs → decentralised, pragmatic and always-on
Shares Diversity action plans with consequences: unmet targets trigger post-approval requirements, Turn Project Orbis into a work-sharing review with one shared assessment report, Conditional approvals that lapse automatically if the confirmatory trial is late, A public registry of cancer treatments that were later shown not to work.
- IdeaApply Project Optimus to drugs already on the market
Shares FDA Oncology Center of Excellence, Wrong doses, Prices and value, Toxicity and quality of life are undervalued.
- CollectionDrugBank & ChEMBL
Shares Every approved cancer drug ships with a public combination-readiness data pack, Require every oncology candidate to publish how much reaches the brain.
- IdeaFund trials that test shorter courses of the most expensive adjuvant drugs
Shares Wrong doses, Incentives reward me-too drugs and marginal gains, Prices and value, Trial design, endpoints and cost.
- IdeaRequire post-approval evidence in patients over 75 and update labels accordingly
Shares Older and multimorbid patients are excluded and undertreated, Weak real-world evidence and registries, Regulatory divergence between regions.
- IdeaDrop the extra switching studies for interchangeable oncology biosimilars
Shares FDA Oncology Center of Excellence, Regulatory divergence between regions, Prices and value.
- IdeaA mandatory over-70s cohort with geriatric assessment in every pivotal trial
Shares Older and multimorbid patients are excluded and undertreated, Wrong doses, Trials do not represent the people who get cancer.
- CollectionESMO Clinical Practice Guidelines & MCBS
Shares Weak real-world evidence and registries, Incentives reward me-too drugs and marginal gains, Regulatory divergence between regions, Prices and value.
institutions
ideas
A 'dose evidence' panel in every label: how many doses were tested, and howA public index of how the same cancer drug's label differs between countriesA public registry of cancer treatments that were later shown not to workConditional approvals that lapse automatically if the confirmatory trial is lateDiversity action plans with consequences: unmet targets trigger post-approval requirementsDrug labels must state which biomarker assays were validated and how they compareEvery approved cancer drug ships with a public combination-readiness data packLive tracker of the lag from first approval to real availability in every countryPrint the participation-to-prevalence ratio in every drug label and assessment reportPublish every complete response letter and negative opinion across all regulatorsRequire every oncology candidate to publish how much reaches the brainTurn Project Orbis into a work-sharing review with one shared assessment report
bottlenecks
AI that is built but not validated or deployedIncentives reward me-too drugs and marginal gainsOlder and multimorbid patients are excluded and undertreatedPrices and valueRegulatory divergence between regionsToxicity and quality of life are undervaluedTrial design, endpoints and costTrials do not represent the people who get cancerWeak real-world evidence and registriesWrong doses