{"entity":{"id":"fda-approvals","kind":"collection","name":"FDA Oncology Approvals (OCE) & Novel Drug Approvals","aka":[],"tldr":"The FDA's oncology approval notifications are the official record of what is approved for what.","summary":"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.","asOf":"2026-09-04","links":[{"label":"Novel Drug Approvals 2026","url":"https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2026"},{"label":"AACR Q1 2026 digest","url":"https://www.aacr.org/blog/2026/04/01/fda-approvals-in-oncology-january-march-2026/"},{"label":"AACR Q2 2026 digest","url":"https://www.aacr.org/blog/2026/07/02/fda-approvals-in-oncology-april-june-2026/"}],"tags":[],"related":[],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"url":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications","holds":"Every oncology approval notification, label, and the annual novel drug list.","license":"Public domain","maintainer":"US FDA Oncology Center of Excellence"},"route":"/collections/fda-approvals/","neighbours":{"bottleneck":[{"id":"b-ai-validation","kind":"bottleneck","name":"AI that is built but not validated or deployed","route":"/bottlenecks/b-ai-validation/"},{"id":"b-incentive-misalignment","kind":"bottleneck","name":"Incentives reward me-too drugs and marginal gains","route":"/bottlenecks/b-incentive-misalignment/"},{"id":"b-aging-comorbidity","kind":"bottleneck","name":"Older and multimorbid patients are excluded and undertreated","route":"/bottlenecks/b-aging-comorbidity/"},{"id":"b-drug-pricing","kind":"bottleneck","name":"Prices and value","route":"/bottlenecks/b-drug-pricing/"},{"id":"b-regulatory-fragmentation","kind":"bottleneck","name":"Regulatory divergence between regions","route":"/bottlenecks/b-regulatory-fragmentation/"},{"id":"b-toxicity-qol","kind":"bottleneck","name":"Toxicity and quality of life are undervalued","route":"/bottlenecks/b-toxicity-qol/"},{"id":"b-trial-design","kind":"bottleneck","name":"Trial design, endpoints and cost","route":"/bottlenecks/b-trial-design/"},{"id":"b-trial-diversity","kind":"bottleneck","name":"Trials do not represent the people who get cancer","route":"/bottlenecks/b-trial-diversity/"},{"id":"b-real-world-evidence","kind":"bottleneck","name":"Weak real-world evidence and registries","route":"/bottlenecks/b-real-world-evidence/"},{"id":"b-dose-optimisation","kind":"bottleneck","name":"Wrong doses","route":"/bottlenecks/b-dose-optimisation/"}],"idea":[{"id":"idea-tr1-dose-evidence-statement-in-label","kind":"idea","name":"A 'dose evidence' panel in every label: how many doses were tested, and how","route":"/ideas/idea-tr1-dose-evidence-statement-in-label/"},{"id":"idea-reg-label-divergence-index","kind":"idea","name":"A public index of how the same cancer drug's label differs between countries","route":"/ideas/idea-reg-label-divergence-index/"},{"id":"idea-tr2-reversal-registry","kind":"idea","name":"A public registry of cancer treatments that were later shown not to work","route":"/ideas/idea-tr2-reversal-registry/"},{"id":"idea-reg-conditional-approval-sunset","kind":"idea","name":"Conditional approvals that lapse automatically if the confirmatory trial is late","route":"/ideas/idea-reg-conditional-approval-sunset/"},{"id":"idea-tr1-diversity-plans-with-consequences","kind":"idea","name":"Diversity action plans with consequences: unmet targets trigger post-approval requirements","route":"/ideas/idea-tr1-diversity-plans-with-consequences/"},{"id":"idea-tr2-label-assay-concordance","kind":"idea","name":"Drug labels must state which biomarker assays were validated and how they compare","route":"/ideas/idea-tr2-label-assay-concordance/"},{"id":"idea-tr2-combo-readiness-dossier","kind":"idea","name":"Every approved cancer drug ships with a public combination-readiness data pack","route":"/ideas/idea-tr2-combo-readiness-dossier/"},{"id":"idea-reg-approval-access-lag-tracker","kind":"idea","name":"Live tracker of the lag from first approval to real availability in every country","route":"/ideas/idea-reg-approval-access-lag-tracker/"},{"id":"idea-tr1-representativeness-in-the-label","kind":"idea","name":"Print the participation-to-prevalence ratio in every drug label and assessment report","route":"/ideas/idea-tr1-representativeness-in-the-label/"},{"id":"idea-reg-publish-all-rejections","kind":"idea","name":"Publish every complete response letter and negative opinion across all regulators","route":"/ideas/idea-reg-publish-all-rejections/"},{"id":"idea-bio2-brain-exposure-disclosure","kind":"idea","name":"Require every oncology candidate to publish how much reaches the brain","route":"/ideas/idea-bio2-brain-exposure-disclosure/"},{"id":"idea-reg-orbis-work-sharing","kind":"idea","name":"Turn Project Orbis into a work-sharing review with one shared assessment report","route":"/ideas/idea-reg-orbis-work-sharing/"}],"journal":[{"id":"clinical-cancer-research","kind":"journal","name":"Clinical Cancer Research","route":"/journals/clinical-cancer-research/"}],"institution":[{"id":"fda-oce","kind":"institution","name":"FDA Oncology Center of Excellence","route":"/institutions/fda-oce/"}]}}