{"generated":"2026-10-17","inputs":{"factcheck":"2026-10-12","trialChanges":"2026-10-12","fda":"2026-10-07","regional":"2026-10-14"},"proposals":[{"kind":"trial-results","confidence":"high","entityId":"nct03709680","entityName":"Study Of Palbociclib Combined With Chemotherapy In Pediatric Patients With Recurrent/Refractory Solid Tumors","entityKind":"trial","route":"/trials/nct03709680/","file":"src/data/pipeline-trials-wave5.ts","line":1415,"editUrl":"https://github.com/judegomila/OnCo/blob/main/src/data/pipeline-trials-wave5.ts#L1415","field":"result / outcomes","current":"(none)","proposed":"add the posted primary outcome with the registry as source","evidence":"ClinicalTrials.gov now has posted results for NCT03709680 (detected 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Editorial statuses (positive, negative, mixed) need the result, so this is a floor, not a verdict.","sourceUrl":"https://clinicaltrials.gov/study/NCT02523014","id":"trial-status:a071401:status:recruiting","detected":"2026-10-17"},{"kind":"trial-status","confidence":"low","entityId":"nct07160686","entityName":"Apixaban to Prevent Venous Thromboembolism in Ambulatory Lung Cancer Patients Undergoing Systemic Anticancer Treatment","entityKind":"trial","route":"/trials/nct07160686/","file":"src/data/spikes/lung-registry-trials.ts","line":980,"editUrl":"https://github.com/judegomila/OnCo/blob/main/src/data/spikes/lung-registry-trials.ts#L980","field":"status","current":"planned","proposed":"recruiting","evidence":"ClinicalTrials.gov overall status is RECRUITING; recorded planned. Editorial statuses (positive, negative, mixed) need the result, so this is a floor, not a verdict.","sourceUrl":"https://clinicaltrials.gov/study/NCT07160686","id":"trial-status:nct07160686:status:recruiting","detected":"2026-10-17"},{"kind":"trial-status","confidence":"low","entityId":"augment-101","entityName":"AUGMENT-101","entityKind":"trial","route":"/trials/augment-101/","file":"src/data/spikes/aml.ts","line":329,"editUrl":"https://github.com/judegomila/OnCo/blob/main/src/data/spikes/aml.ts#L329","field":"status","current":"positive","proposed":"recruiting","evidence":"ClinicalTrials.gov overall status is RECRUITING; recorded positive. Editorial statuses (positive, negative, mixed) need the result, so this is a floor, not a verdict.","sourceUrl":"https://clinicaltrials.gov/study/NCT04065399","id":"trial-status:augment-101:status:recruiting","detected":"2026-10-17"},{"kind":"trial-status","confidence":"low","entityId":"nct06787339","entityName":"Capecitabine in Low Risk Triple Negative Breast Cancer","entityKind":"trial","route":"/trials/nct06787339/","file":"src/data/spikes/tnbc-registry-trials.ts","line":457,"editUrl":"https://github.com/judegomila/OnCo/blob/main/src/data/spikes/tnbc-registry-trials.ts#L457","field":"status","current":"planned","proposed":"recruiting","evidence":"ClinicalTrials.gov overall status is RECRUITING; recorded planned. Editorial statuses (positive, negative, mixed) need the result, so this is a floor, not a verdict.","sourceUrl":"https://clinicaltrials.gov/study/NCT06787339","id":"trial-status:nct06787339:status:recruiting","detected":"2026-10-17"},{"kind":"trial-status","confidence":"low","entityId":"nct07705919","entityName":"DCE-MRI for Neoadjuvant Treatment Assessment in Patients With Borderline Resectable Pancreatic Cancer","entityKind":"trial","route":"/trials/nct07705919/","file":"src/data/spikes/pancreatic-registry-trials.ts","line":248,"editUrl":"https://github.com/judegomila/OnCo/blob/main/src/data/spikes/pancreatic-registry-trials.ts#L248","field":"status","current":"planned","proposed":"recruiting","evidence":"ClinicalTrials.gov overall status is RECRUITING; recorded planned. Editorial statuses (positive, negative, mixed) need the result, so this is a floor, not a verdict.","sourceUrl":"https://clinicaltrials.gov/study/NCT07705919","id":"trial-status:nct07705919:status:recruiting","detected":"2026-10-17"},{"kind":"trial-status","confidence":"low","entityId":"nct07670312","entityName":"Evaluation of XYA02 in Patients With Advanced Solid Tumors","entityKind":"trial","route":"/trials/nct07670312/","file":"src/data/spikes/pancreatic-registry-trials.ts","line":266,"editUrl":"https://github.com/judegomila/OnCo/blob/main/src/data/spikes/pancreatic-registry-trials.ts#L266","field":"status","current":"planned","proposed":"recruiting","evidence":"ClinicalTrials.gov overall status is RECRUITING; recorded planned. Editorial statuses (positive, negative, mixed) need the result, so this is a floor, not a verdict.","sourceUrl":"https://clinicaltrials.gov/study/NCT07670312","id":"trial-status:nct07670312:status:recruiting","detected":"2026-10-17"},{"kind":"trial-status","confidence":"low","entityId":"firefly-1","entityName":"FIREFLY-1","entityKind":"trial","route":"/trials/firefly-1/","file":"src/data/paediatric-fronts.ts","line":31,"editUrl":"https://github.com/judegomila/OnCo/blob/main/src/data/paediatric-fronts.ts#L31","field":"status","current":"positive","proposed":"recruiting","evidence":"ClinicalTrials.gov overall status is RECRUITING; recorded positive. Editorial statuses (positive, negative, mixed) need the result, so this is a floor, not a verdict.","sourceUrl":"https://clinicaltrials.gov/study/NCT04775485","id":"trial-status:firefly-1:status:recruiting","detected":"2026-10-17"},{"kind":"trial-status","confidence":"low","entityId":"nct07299409","entityName":"First-Line Sacituzumab Govitecan in Advanced Untreated Triple-Negative Breast Cancer Patients.","entityKind":"trial","route":"/trials/nct07299409/","file":"src/data/spikes/tnbc-registry-trials.ts","line":189,"editUrl":"https://github.com/judegomila/OnCo/blob/main/src/data/spikes/tnbc-registry-trials.ts#L189","field":"status","current":"planned","proposed":"recruiting","evidence":"ClinicalTrials.gov overall status is RECRUITING; recorded planned. Editorial statuses (positive, negative, mixed) need the result, so this is a floor, not a verdict.","sourceUrl":"https://clinicaltrials.gov/study/NCT07299409","id":"trial-status:nct07299409:status:recruiting","detected":"2026-10-17"},{"kind":"trial-status","confidence":"low","entityId":"linker-mm1","entityName":"LINKER-MM1","entityKind":"trial","route":"/trials/linker-mm1/","file":"src/data/spikes/multiple-myeloma.ts","line":226,"editUrl":"https://github.com/judegomila/OnCo/blob/main/src/data/spikes/multiple-myeloma.ts#L226","field":"status","current":"positive","proposed":"recruiting","evidence":"ClinicalTrials.gov overall status is RECRUITING; recorded positive. Editorial statuses (positive, negative, mixed) need the result, so this is a floor, not a verdict.","sourceUrl":"https://clinicaltrials.gov/study/NCT03761108","id":"trial-status:linker-mm1:status:recruiting","detected":"2026-10-17"},{"kind":"trial-status","confidence":"low","entityId":"nct07723482","entityName":"ML-016 in Advanced Cancer With Lung and/or Liver Involvement","entityKind":"trial","route":"/trials/nct07723482/","file":"src/data/spikes/lung-registry-trials.ts","line":457,"editUrl":"https://github.com/judegomila/OnCo/blob/main/src/data/spikes/lung-registry-trials.ts#L457","field":"status","current":"planned","proposed":"recruiting","evidence":"ClinicalTrials.gov overall status is RECRUITING; recorded planned. Editorial statuses (positive, negative, mixed) need the result, so this is a floor, not a verdict.","sourceUrl":"https://clinicaltrials.gov/study/NCT07723482","id":"trial-status:nct07723482:status:recruiting","detected":"2026-10-17"},{"kind":"trial-status","confidence":"low","entityId":"monumental-1","entityName":"MonumenTAL-1","entityKind":"trial","route":"/trials/monumental-1/","file":"src/data/spikes/multiple-myeloma.ts","line":219,"editUrl":"https://github.com/judegomila/OnCo/blob/main/src/data/spikes/multiple-myeloma.ts#L219","field":"status","current":"positive","proposed":"recruiting","evidence":"ClinicalTrials.gov overall status is RECRUITING; recorded positive. Editorial statuses (positive, negative, mixed) need the result, so this is a floor, not a verdict.","sourceUrl":"https://clinicaltrials.gov/study/NCT04634552","id":"trial-status:monumental-1:status:recruiting","detected":"2026-10-17"},{"kind":"trial-status","confidence":"low","entityId":"nct07509008","entityName":"Phase 1/2 Window Of Opportunity Study Of TROP2 CAR/IL-15 TGFBR2 KO NK Cells Delivered Intraperitoneally For The Management Of Gastric Cancer Metastatic To The Peritoneum","entityKind":"trial","route":"/trials/nct07509008/","file":"src/data/trials.ts","line":1,"editUrl":"https://github.com/judegomila/OnCo/blob/main/src/data/trials.ts#L1","field":"status","current":"planned","proposed":"recruiting","evidence":"ClinicalTrials.gov overall status is RECRUITING; recorded planned. Editorial statuses (positive, negative, mixed) need the result, so this is a floor, not a verdict.","sourceUrl":"https://clinicaltrials.gov/study/NCT07509008","id":"trial-status:nct07509008:status:recruiting","detected":"2026-10-17"},{"kind":"trial-status","confidence":"low","entityId":"nct07271355","entityName":"Pressurized Intraperitoneal Aerosolized Chemotherapy With Mitomycin for the Treatment of Unresectable Appendix or Colorectal Cancer With Peritoneal Metastases,","entityKind":"trial","route":"/trials/nct07271355/","file":"src/data/spikes/colorectal-registry-trials.ts","line":624,"editUrl":"https://github.com/judegomila/OnCo/blob/main/src/data/spikes/colorectal-registry-trials.ts#L624","field":"status","current":"planned","proposed":"recruiting","evidence":"ClinicalTrials.gov overall status is RECRUITING; recorded planned. Editorial statuses (positive, negative, mixed) need the result, so this is a floor, not a verdict.","sourceUrl":"https://clinicaltrials.gov/study/NCT07271355","id":"trial-status:nct07271355:status:recruiting","detected":"2026-10-17"},{"kind":"trial-status","confidence":"low","entityId":"nct06788171","entityName":"PULSAR Combined With PD-1 Ab and Chemotherapy Plus Bev. for CRLM","entityKind":"trial","route":"/trials/nct06788171/","file":"src/data/spikes/colorectal-registry-trials.ts","line":2537,"editUrl":"https://github.com/judegomila/OnCo/blob/main/src/data/spikes/colorectal-registry-trials.ts#L2537","field":"status","current":"planned","proposed":"recruiting","evidence":"ClinicalTrials.gov overall status is RECRUITING; recorded planned. Editorial statuses (positive, negative, mixed) need the result, so this is a floor, not a verdict.","sourceUrl":"https://clinicaltrials.gov/study/NCT06788171","id":"trial-status:nct06788171:status:recruiting","detected":"2026-10-17"},{"kind":"trial-status","confidence":"low","entityId":"nct07469306","entityName":"Short-Course RT Plus CAPOX and Tislelizumab vs Long-Course CRT Plus Tislelizumab for Locally Advanced Rectal Cancer","entityKind":"trial","route":"/trials/nct07469306/","file":"src/data/spikes/colorectal-registry-trials.ts","line":3665,"editUrl":"https://github.com/judegomila/OnCo/blob/main/src/data/spikes/colorectal-registry-trials.ts#L3665","field":"status","current":"planned","proposed":"recruiting","evidence":"ClinicalTrials.gov overall status is RECRUITING; recorded planned. Editorial statuses (positive, negative, mixed) need the result, so this is a floor, not a verdict.","sourceUrl":"https://clinicaltrials.gov/study/NCT07469306","id":"trial-status:nct07469306:status:recruiting","detected":"2026-10-17"},{"kind":"new-product","confidence":"low","entityName":"Nezglyal","field":"new drug record","current":"(not in corpus)","proposed":"add product leriglitazone (Nezglyal) with the EU status the register page shows","evidence":"EMA register: Nezglyal (leriglitazone) Authorised, 2026-09-21. Register page: \"Authorised: This medicine is authorised for use in the European Union\", authorised 2026-09-21, opinion Positive 2026-07-23.","sourceUrl":"https://www.ema.europa.eu/en/medicines/human/EPAR/nezglyal","reason":"no corpus product is named exactly leriglitazone / leriglitazone / Nezglyal","id":"new-product:nezglyal:new-drug-record:add-product-leriglitazone-nezglyal-with-the-eu-status-the-register-page-shows","detected":"2026-10-17"},{"kind":"new-product","confidence":"low","entityName":"Waskyra","field":"new drug record","current":"(not in corpus)","proposed":"add product etuvetidigene autotemcel (Waskyra) with the EU status the register page shows","evidence":"EMA register: Waskyra (etuvetidigene autotemcel) Authorised, 2026-01-09. Register page: \"Authorised: This medicine is authorised for use in the European Union\", authorised 2026-01-09.","sourceUrl":"https://www.ema.europa.eu/en/medicines/human/EPAR/waskyra","reason":"no corpus product is named exactly etuvetidigene autotemcel / genetically modified autologous CD34+ cell enriched population that contains haematopoietic stem and progenitor cells (HSPC) transduced ex vivo using a lentiviral vector encoding the human Wiskott-Aldrich Syndrome (WAS) gene / Waskyra","id":"new-product:waskyra:new-drug-record:add-product-etuvetidigene-autotemcel-waskyra-with-the-eu-status-the-register-page-shows","detected":"2026-10-17"},{"kind":"new-product","confidence":"low","entityName":"Lynkuet","field":"new drug record","current":"(not in corpus)","proposed":"add product elinzanetant (Lynkuet) with the EU status the register page shows","evidence":"EMA register: Lynkuet (elinzanetant) Authorised, 2025-11-17. Register page: \"Authorised: This medicine is authorised for use in the European Union\", authorised 2025-11-17.","sourceUrl":"https://www.ema.europa.eu/en/medicines/human/EPAR/lynkuet","reason":"no corpus product is named exactly elinzanetant / elinzanetant / Lynkuet","id":"new-product:lynkuet:new-drug-record:add-product-elinzanetant-lynkuet-with-the-eu-status-the-register-page-shows","detected":"2026-10-17"},{"kind":"new-product","confidence":"low","entityName":"Casgevy","field":"new drug record","current":"(not in corpus)","proposed":"add product exagamglogene autotemcel (Casgevy) with the EU status the register page shows","evidence":"EMA register: Casgevy (exagamglogene autotemcel) Authorised, 2024-02-09. Register page: \"Authorised: This medicine is authorised for use in the European Union\", authorised 2024-02-09.","sourceUrl":"https://www.ema.europa.eu/en/medicines/human/EPAR/casgevy","reason":"no corpus product is named exactly exagamglogene autotemcel / Exagamglogene autotemcel / Casgevy","id":"new-product:casgevy:new-drug-record:add-product-exagamglogene-autotemcel-casgevy-with-the-eu-status-the-register-page-shows","detected":"2026-10-17"},{"kind":"new-product","confidence":"low","entityName":"Libmeldy","field":"new drug record","current":"(not in corpus)","proposed":"add product autologous CD34+ cells encoding ARSA gene (Libmeldy) with the EU status the register page shows","evidence":"EMA register: Libmeldy (autologous CD34+ cells encoding ARSA gene) Authorised, 2020-12-17. Register page: \"Authorised: This medicine is authorised for use in the European Union\", authorised 2020-12-17.","sourceUrl":"https://www.ema.europa.eu/en/medicines/human/EPAR/libmeldy","reason":"no corpus product is named exactly autologous CD34+ cells encoding ARSA gene / atidarsagene autotemcel / Libmeldy","id":"new-product:libmeldy:new-drug-record:add-product-autologous-cd34-cells-encoding-arsa-gene-libmeldy-with-the-eu-status-the-register-page-shows","detected":"2026-10-17"},{"kind":"new-product","confidence":"low","entityName":"Lumeblue (previously Methylthioninium chloride Cosmo)","field":"new drug record","current":"(not in corpus)","proposed":"add product methylthioninium chloride (Lumeblue (previously Methylthioninium chloride Cosmo)) with the EU status the register page shows","evidence":"EMA register: Lumeblue (previously Methylthioninium chloride Cosmo) (methylthioninium chloride) Authorised, 2020-08-19. Register page: \"Authorised: This medicine is authorised for use in the European Union\", authorised 2020-08-19.","sourceUrl":"https://www.ema.europa.eu/en/medicines/human/EPAR/lumeblue","reason":"no corpus product is named exactly methylthioninium chloride / methylthioninium chloride / Lumeblue (previously Methylthioninium chloride Cosmo)","id":"new-product:lumeblue-previously-methylthioninium-chloride-cosmo-:new-drug-record:add-product-methylthioninium-chloride-lumeblue-previously-methylthioninium-chlo","detected":"2026-10-17"},{"kind":"new-product","confidence":"low","entityName":"Xromi","field":"new drug record","current":"(not in corpus)","proposed":"add product hydroxycarbamide (Xromi) with the EU status the register page shows","evidence":"EMA register: Xromi (hydroxycarbamide) Authorised, 2019-07-01. Register page: \"Authorised: This medicine is authorised for use in the European Union\", authorised 2019-07-01.","sourceUrl":"https://www.ema.europa.eu/en/medicines/human/EPAR/xromi","reason":"no corpus product is named exactly hydroxycarbamide / hydroxycarbamide / Xromi","id":"new-product:xromi:new-drug-record:add-product-hydroxycarbamide-xromi-with-the-eu-status-the-register-page-shows","detected":"2026-10-17"},{"kind":"new-product","confidence":"low","entityName":"SomaKit TOC","field":"new drug record","current":"(not in corpus)","proposed":"add product edotreotide (SomaKit TOC) with the EU status the register page shows","evidence":"EMA register: SomaKit TOC (edotreotide) Authorised, 2016-12-08. Register page: \"Authorised: This medicine is authorised for use in the European Union\", authorised 2016-12-08.","sourceUrl":"https://www.ema.europa.eu/en/medicines/human/EPAR/somakit-toc","reason":"no corpus product is named exactly edotreotide / edotreotide / SomaKit TOC","id":"new-product:somakit-toc:new-drug-record:add-product-edotreotide-somakit-toc-with-the-eu-status-the-register-page-shows","detected":"2026-10-17"},{"kind":"new-product","confidence":"low","entityName":"Strimvelis","field":"new drug record","current":"(not in corpus)","proposed":"add product autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA cDNA sequence (Strimvelis) with the EU status the register page shows","evidence":"EMA register: Strimvelis (autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA cDNA sequence) Authorised, 2016-05-26. Register page: \"Authorised: This medicine is authorised for use in the European Union\", authorised 2016-05-26.","sourceUrl":"https://www.ema.europa.eu/en/medicines/human/EPAR/strimvelis","reason":"no corpus product is named exactly autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA cDNA sequence / autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human adenosine deaminase (ADA) cDNA sequence from human haematopoietic stem/progenitor (CD34+) cells / Strimvelis","id":"new-product:strimvelis:new-drug-record:add-product-autologous-cd34-enriched-cell-fraction-that-contains-cd34-cells-transduced-with-retroviral-vector-that-encode","detected":"2026-10-17"},{"kind":"new-product","confidence":"low","entityName":"Entyvio","field":"new drug record","current":"(not in corpus)","proposed":"add product vedolizumab (Entyvio) with the EU status the register page shows","evidence":"EMA register: Entyvio (vedolizumab) Authorised, 2014-05-22. Register page: \"Authorised: This medicine is authorised for use in the European Union\", authorised 2014-05-22.","sourceUrl":"https://www.ema.europa.eu/en/medicines/human/EPAR/entyvio","reason":"no corpus product is named exactly vedolizumab / vedolizumab / Entyvio","id":"new-product:entyvio:new-drug-record:add-product-vedolizumab-entyvio-with-the-eu-status-the-register-page-shows","detected":"2026-10-17"},{"kind":"new-product","confidence":"low","entityName":"Procysbi","field":"new drug record","current":"(not in corpus)","proposed":"add product mercaptamine (Procysbi) with the EU status the register page shows","evidence":"EMA register: Procysbi (mercaptamine) Authorised, 2013-09-05. Register page: \"Authorised: This medicine is authorised for use in the European Union\", authorised 2013-09-05.","sourceUrl":"https://www.ema.europa.eu/en/medicines/human/EPAR/procysbi","reason":"no corpus product is named exactly mercaptamine / mercaptamine bitartrate / Procysbi","id":"new-product:procysbi:new-drug-record:add-product-mercaptamine-procysbi-with-the-eu-status-the-register-page-shows","detected":"2026-10-17"},{"kind":"new-product","confidence":"low","entityName":"NeoRecormon","field":"new drug record","current":"(not in corpus)","proposed":"add product epoetin beta (NeoRecormon) with the EU status the register page shows","evidence":"EMA register: NeoRecormon (epoetin beta) Authorised, 1997-07-16. Register page: \"Authorised: This medicine is authorised for use in the European Union\", authorised 1997-07-16.","sourceUrl":"https://www.ema.europa.eu/en/medicines/human/EPAR/neorecormon","reason":"no corpus product is named exactly epoetin beta / epoetin beta / NeoRecormon","id":"new-product:neorecormon:new-drug-record:add-product-epoetin-beta-neorecormon-with-the-eu-status-the-register-page-shows","detected":"2026-10-17"},{"kind":"new-product","confidence":"low","entityName":"Cystagon","field":"new drug record","current":"(not in corpus)","proposed":"add product mercaptamine bitartrate (Cystagon) with the EU status the register page shows","evidence":"EMA register: Cystagon (mercaptamine bitartrate) Authorised, 1997-06-23. Register page: \"Authorised: This medicine is authorised for use in the European Union\", authorised 1997-06-23.","sourceUrl":"https://www.ema.europa.eu/en/medicines/human/EPAR/cystagon","reason":"no corpus product is named exactly mercaptamine bitartrate / mercaptamine bitartrate / Cystagon","id":"new-product:cystagon:new-drug-record:add-product-mercaptamine-bitartrate-cystagon-with-the-eu-status-the-register-page-shows","detected":"2026-10-17"},{"kind":"new-product","confidence":"low","entityName":"Yartemlea","field":"new drug record","current":"(not in corpus)","proposed":"add product Narsoplimab (Yartemlea) with the EU status the register page shows","evidence":"EMA register: Yartemlea (Narsoplimab) Opinion under re-examination. Register page: \"Opinion: EMA has issued an opinion on this medicine\", opinion Negative 2026-10-15.","sourceUrl":"https://www.ema.europa.eu/en/medicines/human/EPAR/yartemlea","reason":"no corpus product is named exactly Narsoplimab / Yartemlea","id":"new-product:yartemlea:new-drug-record:add-product-narsoplimab-yartemlea-with-the-eu-status-the-register-page-shows","detected":"2026-10-17"},{"kind":"new-product","confidence":"low","entityName":"Zefylti","field":"new drug record","current":"(not in corpus)","proposed":"add product filgrastim (Zefylti) with the EU status the register page shows","evidence":"EMA register: Zefylti (filgrastim) Application withdrawn. 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