{"generated":"2026-09-17","inputs":{"factcheck":"2026-09-13","trialChanges":"2026-09-14","fda":"2026-09-16","regional":"2026-09-16"},"proposals":[{"kind":"regional-row","confidence":"high","entityId":"dorocubicel","entityName":"Dorocubicel (UM171-expanded cord blood)","entityKind":"drug","route":"/drugs/dorocubicel/","file":"src/data/regional-approvals.ts","field":"EU","current":"(no EU entry)","proposed":"EU: C(2025, \"https://www.ema.europa.eu/en/medicines/human/EPAR/zemcelpro\", \"Treatment of adult patients with haematological malignancies requiring an alloge\")","evidence":"EMA register: Zemcelpro (allogeneic umbilical cord-derived CD34- cells, non-expanded;dorocubicel) Authorised (conditional), 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2013-07-25.","sourceUrl":"https://www.ema.europa.eu/en/medicines/human/EPAR/lonquex","id":"regional-row:lipegfilgrastim:eu:eu:-a-2013-https:-www.ema.europa.eu-en-medicines-human-epar-lonquex-lonquex-is-indicated-in-adults-and-in-children-2-years-of-ag","detected":"2026-09-17"},{"kind":"regional-row","confidence":"high","entityId":"ziv-aflibercept","entityName":"Ziv-aflibercept","entityKind":"drug","route":"/drugs/ziv-aflibercept/","file":"src/data/regional-approvals.ts","field":"EU","current":"(no EU entry)","proposed":"EU: A(2013, \"https://www.ema.europa.eu/en/medicines/human/EPAR/zaltrap\", \"Treatment of metastatic colorectal cancer (MCRC).\")","evidence":"EMA register: Zaltrap (aflibercept) Authorised, 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2012-03-09.","sourceUrl":"https://www.ema.europa.eu/en/medicines/human/EPAR/xaluprine","id":"regional-row:mercaptopurine:eu:eu:-a-2012-https:-www.ema.europa.eu-en-medicines-human-epar-xaluprine-xaluprine-is-indicated-for-the-treatment-of-acute-lymphobla","detected":"2026-09-17"},{"kind":"regional-row","confidence":"high","entityId":"tegafur-gimeracil-oteracil","entityName":"Tegafur, gimeracil and oteracil (S-1)","entityKind":"drug","route":"/drugs/tegafur-gimeracil-oteracil/","file":"src/data/regional-approvals.ts","field":"EU","current":"(no EU entry)","proposed":"EU: A(2011, \"https://www.ema.europa.eu/en/medicines/human/EPAR/teysuno\", \"Teysuno is indicated in adults: - for the treatment of advanced gastric cancer w\")","evidence":"EMA register: Teysuno (tegafur;gimeracil;oteracil) Authorised, 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[90Y]-radiolabelled Zevalin is indicated as cons\")","evidence":"EMA register: Zevalin (ibritumomab tiuxetan) Lapsed, 2004-01-16.","sourceUrl":"https://www.ema.europa.eu/en/medicines/human/EPAR/zevalin","id":"regional-row:ibritumomab-tiuxetan:eu:eu:-a-2004-https:-www.ema.europa.eu-en-medicines-human-epar-zevalin-zevalin-is-indicated-in-adults.-90y--radiolabelled-zeva","detected":"2026-09-17"},{"kind":"regional-row","confidence":"high","entityId":"aprepitant","entityName":"Aprepitant (and fosaprepitant)","entityKind":"drug","route":"/drugs/aprepitant/","file":"src/data/regional-approvals.ts","field":"EU","current":"(no EU entry)","proposed":"EU: A(2003, \"https://www.ema.europa.eu/en/medicines/human/EPAR/emend\", \"Emend 40 mg hard capsules is indicated for the prevention of postoperative nause\")","evidence":"EMA register: Emend (aprepitant) Authorised, 2003-11-11.","sourceUrl":"https://www.ema.europa.eu/en/medicines/human/EPAR/emend","id":"regional-row:aprepitant:eu:eu:-a-2003-https:-www.ema.europa.eu-en-medicines-human-epar-emend-emend-40-mg-hard-capsules-is-indicated-for-the-prevention-of-postop","detected":"2026-09-17"},{"kind":"regional-row","confidence":"high","entityId":"busulfan","entityName":"Busulfan","entityKind":"drug","route":"/drugs/busulfan/","file":"src/data/regional-approvals.ts","field":"EU","current":"(no EU entry)","proposed":"EU: A(2003, \"https://www.ema.europa.eu/en/medicines/human/EPAR/busilvex\", \"Busilvex followed by cyclophosphamide (BuCy2) is indicated as conditioning treat\")","evidence":"EMA register: Busilvex (busulfan) Withdrawn, 2003-07-09.","sourceUrl":"https://www.ema.europa.eu/en/medicines/human/EPAR/busilvex","id":"regional-row:busulfan:eu:eu:-a-2003-https:-www.ema.europa.eu-en-medicines-human-epar-busilvex-busilvex-followed-by-cyclophosphamide-bucy2-is-indicated-as-condit","detected":"2026-09-17"},{"kind":"regional-row","confidence":"high","entityId":"pegfilgrastim","entityName":"Pegfilgrastim","entityKind":"drug","route":"/drugs/pegfilgrastim/","file":"src/data/regional-approvals.ts","field":"EU","current":"(no EU entry)","proposed":"EU: A(2002, \"https://www.ema.europa.eu/en/medicines/human/EPAR/neulasta\", \"Reduction in the duration of neutropenia and the incidence of febrile neutropeni\")","evidence":"EMA register: Neulasta (pegfilgrastim) Authorised, 2002-08-22.","sourceUrl":"https://www.ema.europa.eu/en/medicines/human/EPAR/neulasta","id":"regional-row:pegfilgrastim:eu:eu:-a-2002-https:-www.ema.europa.eu-en-medicines-human-epar-neulasta-reduction-in-the-duration-of-neutropenia-and-the-incidence-of","detected":"2026-09-17"},{"kind":"regional-row","confidence":"high","entityId":"temoporfin","entityName":"Temoporfin","entityKind":"drug","route":"/drugs/temoporfin/","file":"src/data/regional-approvals.ts","field":"EU","current":"(no EU entry)","proposed":"EU: A(2001, \"https://www.ema.europa.eu/en/medicines/human/EPAR/foscan\", \"Foscan is indicated for the palliative treatment of patients with advanced head \")","evidence":"EMA register: Foscan (temoporfin) Authorised, 2001-10-24.","sourceUrl":"https://www.ema.europa.eu/en/medicines/human/EPAR/foscan","id":"regional-row:temoporfin:eu:eu:-a-2001-https:-www.ema.europa.eu-en-medicines-human-epar-foscan-foscan-is-indicated-for-the-palliative-treatment-of-patients-with-","detected":"2026-09-17"},{"kind":"regional-row","confidence":"high","entityId":"cytarabine","entityName":"Cytarabine","entityKind":"drug","route":"/drugs/cytarabine/","file":"src/data/regional-approvals.ts","field":"EU","current":"(no EU entry)","proposed":"EU: A(2001, \"https://www.ema.europa.eu/en/medicines/human/EPAR/depocyte\", \"Intrathecal treatment of lymphomatous meningitis. 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withdrawn.","sourceUrl":"https://www.ema.europa.eu/en/medicines/human/EPAR/zumrad","id":"regional-row:sasanlimab:eu:eu:-a-year-https:-www.ema.europa.eu-en-medicines-human-epar-zumrad-treatment-of-bladder-cancer-in-adults-indicated-for-the-treatment-","detected":"2026-09-17"},{"kind":"regional-row","confidence":"high","entityId":"filgrastim","entityName":"Filgrastim (G-CSF)","entityKind":"drug","route":"/drugs/filgrastim/","file":"src/data/regional-approvals.ts","field":"EU","current":"(no EU entry)","proposed":"EU: A(<year>, \"https://www.ema.europa.eu/en/medicines/human/EPAR/zefylti-0\", \"Zefylti is indicated for the reduction in the duration of neutropenia and the in\")","evidence":"EMA register: Zefylti (filgrastim) Application withdrawn.","sourceUrl":"https://www.ema.europa.eu/en/medicines/human/EPAR/zefylti-0","id":"regional-row:filgrastim:eu:eu:-a-year-https:-www.ema.europa.eu-en-medicines-human-epar-zefylti-0-zefylti-is-indicated-for-the-reduction-in-the-duration-of-neutr","detected":"2026-09-17"},{"kind":"regional-row","confidence":"high","entityId":"omacetaxine","entityName":"Omacetaxine mepesuccinate","entityKind":"drug","route":"/drugs/omacetaxine/","file":"src/data/regional-approvals.ts","field":"EU","current":"(no EU entry)","proposed":"EU: A(<year>, \"https://www.ema.europa.eu/en/medicines/human/EPAR/tekinex\", \"\")","evidence":"EMA register: Tekinex () Application withdrawn.","sourceUrl":"https://www.ema.europa.eu/en/medicines/human/EPAR/tekinex","id":"regional-row:omacetaxine:eu:eu:-a-year-https:-www.ema.europa.eu-en-medicines-human-epar-tekinex-","detected":"2026-09-17"},{"kind":"regional-row","confidence":"high","entityId":"ixabepilone","entityName":"Ixabepilone","entityKind":"drug","route":"/drugs/ixabepilone/","file":"src/data/regional-approvals.ts","field":"EU","current":"(no EU entry)","proposed":"EU: A(<year>, \"https://www.ema.europa.eu/en/medicines/human/EPAR/ixempra\", \"\")","evidence":"EMA register: Ixempra () Application withdrawn.","sourceUrl":"https://www.ema.europa.eu/en/medicines/human/EPAR/ixempra","id":"regional-row:ixabepilone:eu:eu:-a-year-https:-www.ema.europa.eu-en-medicines-human-epar-ixempra-","detected":"2026-09-17"},{"kind":"regional-row","confidence":"high","entityId":"vorinostat","entityName":"Vorinostat","entityKind":"drug","route":"/drugs/vorinostat/","file":"src/data/regional-approvals.ts","field":"EU","current":"(no EU entry)","proposed":"EU: A(<year>, \"https://www.ema.europa.eu/en/medicines/human/EPAR/vorinostat-msd\", \"\")","evidence":"EMA register: Vorinostat MSD () Application withdrawn.","sourceUrl":"https://www.ema.europa.eu/en/medicines/human/EPAR/vorinostat-msd","id":"regional-row:vorinostat:eu:eu:-a-year-https:-www.ema.europa.eu-en-medicines-human-epar-vorinostat-msd-","detected":"2026-09-17"},{"kind":"regulatory-event","confidence":"high","entityId":"sevabertinib","entityName":"Sevabertinib","entityKind":"drug","route":"/drugs/sevabertinib/","file":"src/data/spikes/nsclc.ts","line":172,"editUrl":"https://github.com/judegomila/OnCo/blob/main/src/data/spikes/nsclc.ts#L172","field":"regulatoryEvents","current":"0 events; none dated 2026-09-09","proposed":"{ date: \"2026-09-09\", type: \"approval\", region: \"US\", note: \"grants accelerated approval to sevabertinib for locally advanced or metastatic non-squamous non-small cell lung cancer (accelerated)\", source: \"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sevabertinib-locally-advanced-or-metastatic-non-squamous-non-small\" }","evidence":"On September 9, 2026, the Food and Drug Administration granted accelerated approval to sevabertinib (Hyrnuo, Bayer Healthcare Pharmaceuticals Inc.), a kinase inhibitor, for adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB","sourceUrl":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sevabertinib-locally-advanced-or-metastatic-non-squamous-non-small","detected":"2026-09-09","id":"regulatory-event:sevabertinib:regulatoryevents:-date:-2026-09-09-type:-approval-region:-us-note:-grants-accelerated-approval-to-sevabertinib-for-locally-advance"},{"kind":"regulatory-event","confidence":"high","entityId":"daraxonrasib","entityName":"Daraxonrasib","entityKind":"drug","route":"/drugs/daraxonrasib/","file":"src/data/drugs.ts","line":520,"editUrl":"https://github.com/judegomila/OnCo/blob/main/src/data/drugs.ts#L520","field":"regulatoryEvents","current":"2 events; none dated 2026-08-26","proposed":"{ date: \"2026-08-26\", type: \"approval\", region: \"US\", note: \"approves daraxonrasib for metastatic pancreatic adenocarcinoma\", source: \"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daraxonrasib-metastatic-pancreatic-adenocarcinoma\" }","evidence":"On August 26, 2026, the Food and Drug Administration approved daraxonrasib (RASONQUE, Revolution Medicines, Inc.), an inhibitor of the RAS GTPase family, for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagen","sourceUrl":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-daraxonrasib-metastatic-pancreatic-adenocarcinoma","detected":"2026-09-09","id":"regulatory-event:daraxonrasib:regulatoryevents:-date:-2026-08-26-type:-approval-region:-us-note:-approves-daraxonrasib-for-metastatic-pancreatic-adenocarcinoma-"},{"kind":"regulatory-event","confidence":"high","entityId":"tislelizumab","entityName":"Tislelizumab","entityKind":"drug","route":"/drugs/tislelizumab/","file":"src/data/spikes/esophageal.ts","line":101,"editUrl":"https://github.com/judegomila/OnCo/blob/main/src/data/spikes/esophageal.ts#L101","field":"regulatoryEvents","current":"3 events; none dated 2026-08-25","proposed":"{ date: \"2026-08-25\", type: \"approval\", region: \"US\", note: \"approves zanidatamab-hrii and tislelizumab-jsgr for HER2-positive gastric, gastroesophageal junction, or esophageal adenocarcinoma\", source: \"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-zanidatamab-hrii-and-tislelizumab-jsgr-her2-positive-gastric-gastroesophageal-junction\" }","evidence":"On August 25, 2026, the Food and Drug Administration approved zanidatamab-hrii (Ziihera, Jazz Pharmaceuticals) in combination with fluoropyrimidine- and platinum-containing chemotherapy and tislelizumab-jsgr (Tevimbra, BeOne Medicines USA, Inc.), as first-line treatment for adults with HER2-positive","sourceUrl":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-zanidatamab-hrii-and-tislelizumab-jsgr-her2-positive-gastric-gastroesophageal-junction","detected":"2026-09-09","id":"regulatory-event:tislelizumab:regulatoryevents:-date:-2026-08-25-type:-approval-region:-us-note:-approves-zanidatamab-hrii-and-tislelizumab-jsgr-for-her2-positi"},{"kind":"regulatory-event","confidence":"high","entityId":"zanidatamab","entityName":"Zanidatamab","entityKind":"drug","route":"/drugs/zanidatamab/","file":"src/data/drugs.ts","line":373,"editUrl":"https://github.com/judegomila/OnCo/blob/main/src/data/drugs.ts#L373","field":"regulatoryEvents","current":"3 events; none dated 2026-08-25","proposed":"{ date: \"2026-08-25\", type: \"approval\", region: \"US\", note: \"approves zanidatamab-hrii and tislelizumab-jsgr for HER2-positive gastric, gastroesophageal junction, or esophageal adenocarcinoma\", source: \"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-zanidatamab-hrii-and-tislelizumab-jsgr-her2-positive-gastric-gastroesophageal-junction\" }","evidence":"On August 25, 2026, the Food and Drug Administration approved zanidatamab-hrii (Ziihera, Jazz Pharmaceuticals) in combination with fluoropyrimidine- and platinum-containing chemotherapy and tislelizumab-jsgr (Tevimbra, BeOne Medicines USA, Inc.), as first-line treatment for adults with HER2-positive","sourceUrl":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-zanidatamab-hrii-and-tislelizumab-jsgr-her2-positive-gastric-gastroesophageal-junction","detected":"2026-09-09","id":"regulatory-event:zanidatamab:regulatoryevents:-date:-2026-08-25-type:-approval-region:-us-note:-approves-zanidatamab-hrii-and-tislelizumab-jsgr-for-her2-positiv"},{"kind":"regulatory-event","confidence":"high","entityId":"dexamethasone","entityName":"Dexamethasone","entityKind":"drug","route":"/drugs/dexamethasone/","file":"src/data/drugs-approved-wave1.ts","line":197,"editUrl":"https://github.com/judegomila/OnCo/blob/main/src/data/drugs-approved-wave1.ts#L197","field":"regulatoryEvents","current":"0 events; none dated 2026-08-13","proposed":"{ date: \"2026-08-13\", type: \"approval\", region: \"US\", note: \"grants accelerated approval to iberdomide with daratumumab and hyaluronidase-fihj and dexamethasone for multiple myeloma (accelerated)\", source: \"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-iberdomide-daratumumab-and-hyaluronidase-fihj-and-dexamethasone\" }","evidence":"On August 13, 2026, the Food and Drug Administration granted accelerated approval to iberdomide (Zenbexus, Bristol-Myers Squibb Company) in combination with daratumumab and hyaluronidase-fihj and dexamethasone for adults with multiple myeloma who have received at least one prior line of therapy incl","sourceUrl":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-iberdomide-daratumumab-and-hyaluronidase-fihj-and-dexamethasone","detected":"2026-09-09","id":"regulatory-event:dexamethasone:regulatoryevents:-date:-2026-08-13-type:-approval-region:-us-note:-grants-accelerated-approval-to-iberdomide-with-daratumumab-and"},{"kind":"regulatory-event","confidence":"high","entityId":"daratumumab","entityName":"Daratumumab","entityKind":"drug","route":"/drugs/daratumumab/","file":"src/data/spikes/multiple-myeloma.ts","line":78,"editUrl":"https://github.com/judegomila/OnCo/blob/main/src/data/spikes/multiple-myeloma.ts#L78","field":"regulatoryEvents","current":"4 events; none dated 2026-08-13","proposed":"{ date: \"2026-08-13\", type: \"approval\", region: \"US\", note: \"grants accelerated approval to iberdomide with daratumumab and hyaluronidase-fihj and dexamethasone for multiple myeloma (accelerated)\", source: \"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-iberdomide-daratumumab-and-hyaluronidase-fihj-and-dexamethasone\" }","evidence":"On August 13, 2026, the Food and Drug Administration granted accelerated approval to iberdomide (Zenbexus, Bristol-Myers Squibb Company) in combination with daratumumab and hyaluronidase-fihj and dexamethasone for adults with multiple myeloma who have received at least one prior line of therapy incl","sourceUrl":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-iberdomide-daratumumab-and-hyaluronidase-fihj-and-dexamethasone","detected":"2026-09-09","id":"regulatory-event:daratumumab:regulatoryevents:-date:-2026-08-13-type:-approval-region:-us-note:-grants-accelerated-approval-to-iberdomide-with-daratumumab-and-h"},{"kind":"regulatory-event","confidence":"high","entityId":"iberdomide","entityName":"Iberdomide","entityKind":"drug","route":"/drugs/iberdomide/","file":"src/data/spikes/multiple-myeloma.ts","line":132,"editUrl":"https://github.com/judegomila/OnCo/blob/main/src/data/spikes/multiple-myeloma.ts#L132","field":"regulatoryEvents","current":"0 events; none dated 2026-08-13","proposed":"{ date: \"2026-08-13\", type: \"approval\", region: \"US\", note: \"grants accelerated approval to iberdomide with daratumumab and hyaluronidase-fihj and dexamethasone for multiple myeloma (accelerated)\", source: \"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-iberdomide-daratumumab-and-hyaluronidase-fihj-and-dexamethasone\" }","evidence":"On August 13, 2026, the Food and Drug Administration granted accelerated approval to iberdomide (Zenbexus, Bristol-Myers Squibb Company) in combination with daratumumab and hyaluronidase-fihj and dexamethasone for adults with multiple myeloma who have received at least one prior line of therapy incl","sourceUrl":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-iberdomide-daratumumab-and-hyaluronidase-fihj-and-dexamethasone","detected":"2026-09-09","id":"regulatory-event:iberdomide:regulatoryevents:-date:-2026-08-13-type:-approval-region:-us-note:-grants-accelerated-approval-to-iberdomide-with-daratumumab-and-hy"},{"kind":"regulatory-event","confidence":"high","entityId":"nivolumab","entityName":"Nivolumab","entityKind":"drug","route":"/drugs/nivolumab/","file":"src/data/drugs.ts","line":252,"editUrl":"https://github.com/judegomila/OnCo/blob/main/src/data/drugs.ts#L252","field":"regulatoryEvents","current":"8 events; none dated 2026-08-06","proposed":"{ date: \"2026-08-06\", type: \"approval\", region: \"US\", note: \"grants accelerated approval to vusolimogene oderparepvec-wtpg in combination with nivolumab for melanoma (accelerated)\", source: \"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-vusolimogene-oderparepvec-wtpg-combination-nivolumab-melanoma\" }","evidence":"On August 6, 2026, the Food and Drug Administration granted accelerated approval to vusolimogene oderparepvec-wtpg (Tudriqev, Replimune, Inc.), a genetically modified oncolytic viral therapy, in combination with nivolumab for the treatment of adult patients with unresectable advanced cutaneous melan","sourceUrl":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-vusolimogene-oderparepvec-wtpg-combination-nivolumab-melanoma","detected":"2026-09-09","id":"regulatory-event:nivolumab:regulatoryevents:-date:-2026-08-06-type:-approval-region:-us-note:-grants-accelerated-approval-to-vusolimogene-oderparepvec-wtpg-in-c"},{"kind":"regulatory-event","confidence":"high","entityId":"relatlimab-nivolumab","entityName":"Relatlimab + nivolumab","entityKind":"drug","route":"/drugs/relatlimab-nivolumab/","file":"src/data/drugs.ts","line":299,"editUrl":"https://github.com/judegomila/OnCo/blob/main/src/data/drugs.ts#L299","field":"regulatoryEvents","current":"2 events; none dated 2026-08-06","proposed":"{ date: \"2026-08-06\", type: \"approval\", region: \"US\", note: \"grants accelerated approval to vusolimogene oderparepvec-wtpg in combination with nivolumab for melanoma (accelerated)\", source: \"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-vusolimogene-oderparepvec-wtpg-combination-nivolumab-melanoma\" }","evidence":"On August 6, 2026, the Food and Drug Administration granted accelerated approval to vusolimogene oderparepvec-wtpg (Tudriqev, Replimune, Inc.), a genetically modified oncolytic viral therapy, in combination with nivolumab for the treatment of adult patients with unresectable advanced cutaneous melan","sourceUrl":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-vusolimogene-oderparepvec-wtpg-combination-nivolumab-melanoma","detected":"2026-09-09","id":"regulatory-event:relatlimab-nivolumab:regulatoryevents:-date:-2026-08-06-type:-approval-region:-us-note:-grants-accelerated-approval-to-vusolimogene-oderparepve"},{"kind":"regulatory-event","confidence":"high","entityId":"zidesamtinib","entityName":"Zidesamtinib","entityKind":"drug","route":"/drugs/zidesamtinib/","file":"src/data/drugs.ts","line":553,"editUrl":"https://github.com/judegomila/OnCo/blob/main/src/data/drugs.ts#L553","field":"regulatoryEvents","current":"2 events; none dated 2026-07-22","proposed":"{ date: \"2026-07-22\", type: \"approval\", region: \"US\", note: \"approves zidesamtinib for ROS1 -positive non-small cell lung cancer\", source: \"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-zidesamtinib-ros1-positive-non-small-cell-lung-cancer\" }","evidence":"On July 22, 2026, the Food and Drug Administration approved zidesamtinib (Jideytro, Nuvalent, Inc.) for adults with locally advanced or metastatic ROS1 -positive non-small cell lung cancer (NSCLC) who received at least one prior ROS1 tyrosine kinase inhibitor (TKI).","sourceUrl":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-zidesamtinib-ros1-positive-non-small-cell-lung-cancer","detected":"2026-09-09","id":"regulatory-event:zidesamtinib:regulatoryevents:-date:-2026-07-22-type:-approval-region:-us-note:-approves-zidesamtinib-for-ros1--positive-non-small-cell-lung-ca"},{"kind":"regulatory-event","confidence":"high","entityId":"fulvestrant","entityName":"Fulvestrant","entityKind":"drug","route":"/drugs/fulvestrant/","file":"src/data/spikes/breast-hr-positive.ts","line":243,"editUrl":"https://github.com/judegomila/OnCo/blob/main/src/data/spikes/breast-hr-positive.ts#L243","field":"regulatoryEvents","current":"0 events; none dated 2026-07-14","proposed":"{ date: \"2026-07-14\", type: \"approval\", region: \"US\", note: \"approves gedatolisib with fulvestrant, with or without palbociclib, for HR-positive, HER2-negative locally advanced or metastatic breast cancer\", source: \"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-gedatolisib-fulvestrant-or-without-palbociclib-hr-positive-her2-negative-locally\" }","evidence":"On July 14, 2026, the Food and Drug Administration approved gedatolisib (Revtorpyk, Celcuity Inc.) in combination with fulvestrant, with or without palbociclib, for adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic bre","sourceUrl":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-gedatolisib-fulvestrant-or-without-palbociclib-hr-positive-her2-negative-locally","detected":"2026-09-09","id":"regulatory-event:fulvestrant:regulatoryevents:-date:-2026-07-14-type:-approval-region:-us-note:-approves-gedatolisib-with-fulvestrant-with-or-without-palbocicli"},{"kind":"regulatory-event","confidence":"high","entityId":"palbociclib","entityName":"Palbociclib","entityKind":"drug","route":"/drugs/palbociclib/","file":"src/data/drugs.ts","line":585,"editUrl":"https://github.com/judegomila/OnCo/blob/main/src/data/drugs.ts#L585","field":"regulatoryEvents","current":"5 events; none dated 2026-07-14","proposed":"{ date: \"2026-07-14\", type: \"approval\", region: \"US\", note: \"approves gedatolisib with fulvestrant, with or without palbociclib, for HR-positive, HER2-negative locally advanced or metastatic breast cancer\", source: \"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-gedatolisib-fulvestrant-or-without-palbociclib-hr-positive-her2-negative-locally\" }","evidence":"On July 14, 2026, the Food and Drug Administration approved gedatolisib (Revtorpyk, Celcuity Inc.) in combination with fulvestrant, with or without palbociclib, for adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic bre","sourceUrl":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-gedatolisib-fulvestrant-or-without-palbociclib-hr-positive-her2-negative-locally","detected":"2026-09-09","id":"regulatory-event:palbociclib:regulatoryevents:-date:-2026-07-14-type:-approval-region:-us-note:-approves-gedatolisib-with-fulvestrant-with-or-without-palbocicli"},{"kind":"regulatory-event","confidence":"high","entityId":"gedatolisib","entityName":"Gedatolisib","entityKind":"drug","route":"/drugs/gedatolisib/","file":"src/data/drugs.ts","line":625,"editUrl":"https://github.com/judegomila/OnCo/blob/main/src/data/drugs.ts#L625","field":"regulatoryEvents","current":"2 events; none dated 2026-07-14","proposed":"{ date: \"2026-07-14\", type: \"approval\", region: \"US\", note: \"approves gedatolisib with fulvestrant, with or without palbociclib, for HR-positive, HER2-negative locally advanced or metastatic breast cancer\", source: \"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-gedatolisib-fulvestrant-or-without-palbociclib-hr-positive-her2-negative-locally\" }","evidence":"On July 14, 2026, the Food and Drug Administration approved gedatolisib (Revtorpyk, Celcuity Inc.) in combination with fulvestrant, with or without palbociclib, for adults with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic bre","sourceUrl":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-gedatolisib-fulvestrant-or-without-palbociclib-hr-positive-her2-negative-locally","detected":"2026-09-09","id":"regulatory-event:gedatolisib:regulatoryevents:-date:-2026-07-14-type:-approval-region:-us-note:-approves-gedatolisib-with-fulvestrant-with-or-without-palbocicli"},{"kind":"regulatory-event","confidence":"high","entityId":"selpercatinib","entityName":"Selpercatinib","entityKind":"drug","route":"/drugs/selpercatinib/","file":"src/data/drugs.ts","line":537,"editUrl":"https://github.com/judegomila/OnCo/blob/main/src/data/drugs.ts#L537","field":"regulatoryEvents","current":"4 events; none dated 2026-07-14","proposed":"{ date: \"2026-07-14\", type: \"approval\", region: \"US\", note: \"grants traditional approval to selpercatinib for locally advanced or metastatic RET fusion-positive solid tumors\", source: \"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-selpercatinib-locally-advanced-or-metastatic-ret-fusion-positive\" }","evidence":"On July 14, 2026, the Food and Drug Administration granted traditional approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult and pediatric patients two years of age and older with locally advanced or metastatic solid tumors with a RET gene fusion, as detected by an FDA-approved test, ","sourceUrl":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-selpercatinib-locally-advanced-or-metastatic-ret-fusion-positive","detected":"2026-09-09","id":"regulatory-event:selpercatinib:regulatoryevents:-date:-2026-07-14-type:-approval-region:-us-note:-grants-traditional-approval-to-selpercatinib-for-locally-advan"},{"kind":"regulatory-event","confidence":"high","entityId":"enfortumab-vedotin","entityName":"Enfortumab vedotin","entityKind":"drug","route":"/drugs/enfortumab-vedotin/","file":"src/data/drugs.ts","line":78,"editUrl":"https://github.com/judegomila/OnCo/blob/main/src/data/drugs.ts#L78","field":"regulatoryEvents","current":"6 events; none dated 2026-07-10","proposed":"{ date: \"2026-07-10\", type: \"approval\", region: \"US\", note: \"approves pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph each with enfortumab vedotin-ejfv for muscle invasive bladder cancer\", source: \"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-or-pembrolizumab-and-berahyaluronidase-alfa-pmph-each-enfortumab-vedotin\" }","evidence":"On July 10, 2026, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) each in combination with enfortumab vedotin-ejfv (Padcev, Astellas Pharma) as neoadjuvant treatment (before surgery) followed by adjuvan","sourceUrl":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-or-pembrolizumab-and-berahyaluronidase-alfa-pmph-each-enfortumab-vedotin","detected":"2026-09-09","id":"regulatory-event:enfortumab-vedotin:regulatoryevents:-date:-2026-07-10-type:-approval-region:-us-note:-approves-pembrolizumab-or-pembrolizumab-and-berahyaluroni"},{"kind":"regulatory-event","confidence":"high","entityId":"pembrolizumab","entityName":"Pembrolizumab","entityKind":"drug","route":"/drugs/pembrolizumab/","file":"src/data/drugs.ts","line":236,"editUrl":"https://github.com/judegomila/OnCo/blob/main/src/data/drugs.ts#L236","field":"regulatoryEvents","current":"10 events; none dated 2026-07-10","proposed":"{ date: \"2026-07-10\", type: \"approval\", region: \"US\", note: \"approves pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph each with enfortumab vedotin-ejfv for muscle invasive bladder cancer\", source: \"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-or-pembrolizumab-and-berahyaluronidase-alfa-pmph-each-enfortumab-vedotin\" }","evidence":"On July 10, 2026, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck) each in combination with enfortumab vedotin-ejfv (Padcev, Astellas Pharma) as neoadjuvant treatment (before surgery) followed by adjuvan","sourceUrl":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-or-pembrolizumab-and-berahyaluronidase-alfa-pmph-each-enfortumab-vedotin","detected":"2026-09-09","id":"regulatory-event:pembrolizumab:regulatoryevents:-date:-2026-07-10-type:-approval-region:-us-note:-approves-pembrolizumab-or-pembrolizumab-and-berahyaluronidase-"},{"kind":"regulatory-event","confidence":"high","entityId":"isatuximab","entityName":"Isatuximab","entityKind":"drug","route":"/drugs/isatuximab/","file":"src/data/spikes/multiple-myeloma.ts","line":88,"editUrl":"https://github.com/judegomila/OnCo/blob/main/src/data/spikes/multiple-myeloma.ts#L88","field":"regulatoryEvents","current":"2 events; none dated 2026-07-09","proposed":"{ date: \"2026-07-09\", type: \"approval\", region: \"US\", note: \"approves isatuximab-irfc for subcutaneous injection for multiple myeloma indications\", source: \"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-isatuximab-irfc-subcutaneous-injection-multiple-myeloma-indications\" }","evidence":"On July 9, 2026, the Food and Drug Administration approved isatuximab-irfc (Sarclisa Escena, Sanofi-Aventis U.S. LLC) for subcutaneous injection for multiple myeloma indications.","sourceUrl":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-isatuximab-irfc-subcutaneous-injection-multiple-myeloma-indications","detected":"2026-09-09","id":"regulatory-event:isatuximab:regulatoryevents:-date:-2026-07-09-type:-approval-region:-us-note:-approves-isatuximab-irfc-for-subcutaneous-injection-for-multiple-"},{"kind":"regulatory-event","confidence":"high","entityId":"sacituzumab-govitecan","entityName":"Sacituzumab govitecan","entityKind":"drug","route":"/drugs/sacituzumab-govitecan/","file":"src/data/drugs.ts","line":10,"editUrl":"https://github.com/judegomila/OnCo/blob/main/src/data/drugs.ts#L10","field":"regulatoryEvents","current":"7 events; none dated 2026-06-24","proposed":"{ date: \"2026-06-24\", type: \"approval\", region: \"US\", note: \"approves sacituzumab govitecan-hziy as monotherapy and in combination with pembrolizumab for first-line treatment of triple-negative breast cancer\", source: \"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sacituzumab-govitecan-hziy-monotherapy-and-combination-pembrolizumab-first-line\" }","evidence":"On June 24, 2026, the Food and Drug Administration approved sacituzumab govitecan-hziy (Trodelvy, Gilead Sciences, Inc.) for two indications in adults with triple-negative breast cancer (TNBC).","sourceUrl":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sacituzumab-govitecan-hziy-monotherapy-and-combination-pembrolizumab-first-line","detected":"2026-09-09","id":"regulatory-event:sacituzumab-govitecan:regulatoryevents:-date:-2026-06-24-type:-approval-region:-us-note:-approves-sacituzumab-govitecan-hziy-as-monotherapy-and"},{"kind":"regulatory-event","confidence":"high","entityId":"pembrolizumab","entityName":"Pembrolizumab","entityKind":"drug","route":"/drugs/pembrolizumab/","file":"src/data/drugs.ts","line":236,"editUrl":"https://github.com/judegomila/OnCo/blob/main/src/data/drugs.ts#L236","field":"regulatoryEvents","current":"10 events; none dated 2026-06-24","proposed":"{ date: \"2026-06-24\", type: \"approval\", region: \"US\", note: \"approves sacituzumab govitecan-hziy as monotherapy and in combination with pembrolizumab for first-line treatment of triple-negative breast cancer\", source: \"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sacituzumab-govitecan-hziy-monotherapy-and-combination-pembrolizumab-first-line\" }","evidence":"On June 24, 2026, the Food and Drug Administration approved sacituzumab govitecan-hziy (Trodelvy, Gilead Sciences, Inc.) for two indications in adults with triple-negative breast cancer (TNBC).","sourceUrl":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-sacituzumab-govitecan-hziy-monotherapy-and-combination-pembrolizumab-first-line","detected":"2026-09-09","id":"regulatory-event:pembrolizumab:regulatoryevents:-date:-2026-06-24-type:-approval-region:-us-note:-approves-sacituzumab-govitecan-hziy-as-monotherapy-and-in-comb"},{"kind":"regulatory-event","confidence":"high","entityId":"palbociclib","entityName":"Palbociclib","entityKind":"drug","route":"/drugs/palbociclib/","file":"src/data/drugs.ts","line":585,"editUrl":"https://github.com/judegomila/OnCo/blob/main/src/data/drugs.ts#L585","field":"regulatoryEvents","current":"5 events; none dated 2026-06-24","proposed":"{ date: \"2026-06-24\", type: \"approval\", region: \"US\", note: \"approves palbociclib with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of HR-positive, HER2-positive metastatic breast cancer\", source: \"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-palbociclib-trastuzumab-or-without-pertuzumab-and-endocrine-therapy-maintenance\" }","evidence":"On June 24, 2026, the Food and Drug Administration approved palbociclib (Ibrance, Pfizer Inc.) in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adults with HR-positive, HER2-positive locally advanced or metastatic breast cancer follo","sourceUrl":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-palbociclib-trastuzumab-or-without-pertuzumab-and-endocrine-therapy-maintenance","detected":"2026-09-09","id":"regulatory-event:palbociclib:regulatoryevents:-date:-2026-06-24-type:-approval-region:-us-note:-approves-palbociclib-with-trastuzumab-with-or-without-pertuzumab"},{"kind":"regulatory-event","confidence":"high","entityId":"trastuzumab","entityName":"Trastuzumab","entityKind":"drug","route":"/drugs/trastuzumab/","file":"src/data/drugs.ts","line":697,"editUrl":"https://github.com/judegomila/OnCo/blob/main/src/data/drugs.ts#L697","field":"regulatoryEvents","current":"6 events; none dated 2026-06-24","proposed":"{ date: \"2026-06-24\", type: \"approval\", region: \"US\", note: \"approves palbociclib with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of HR-positive, HER2-positive metastatic breast cancer\", source: \"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-palbociclib-trastuzumab-or-without-pertuzumab-and-endocrine-therapy-maintenance\" }","evidence":"On June 24, 2026, the Food and Drug Administration approved palbociclib (Ibrance, Pfizer Inc.) in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adults with HR-positive, HER2-positive locally advanced or metastatic breast cancer follo","sourceUrl":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-palbociclib-trastuzumab-or-without-pertuzumab-and-endocrine-therapy-maintenance","detected":"2026-09-09","id":"regulatory-event:trastuzumab:regulatoryevents:-date:-2026-06-24-type:-approval-region:-us-note:-approves-palbociclib-with-trastuzumab-with-or-without-pertuzumab"},{"kind":"regulatory-event","confidence":"high","entityId":"pertuzumab","entityName":"Pertuzumab","entityKind":"drug","route":"/drugs/pertuzumab/","file":"src/data/spikes/breast-her2-positive.ts","line":168,"editUrl":"https://github.com/judegomila/OnCo/blob/main/src/data/spikes/breast-her2-positive.ts#L168","field":"regulatoryEvents","current":"4 events; none dated 2026-06-24","proposed":"{ date: \"2026-06-24\", type: \"approval\", region: \"US\", note: \"approves palbociclib with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of HR-positive, HER2-positive metastatic breast cancer\", source: \"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-palbociclib-trastuzumab-or-without-pertuzumab-and-endocrine-therapy-maintenance\" }","evidence":"On June 24, 2026, the Food and Drug Administration approved palbociclib (Ibrance, Pfizer Inc.) in combination with trastuzumab, with or without pertuzumab, and endocrine therapy for the maintenance treatment of adults with HR-positive, HER2-positive locally advanced or metastatic breast cancer follo","sourceUrl":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-palbociclib-trastuzumab-or-without-pertuzumab-and-endocrine-therapy-maintenance","detected":"2026-09-09","id":"regulatory-event:pertuzumab:regulatoryevents:-date:-2026-06-24-type:-approval-region:-us-note:-approves-palbociclib-with-trastuzumab-with-or-without-pertuzumab-"},{"kind":"regulatory-event","confidence":"high","entityId":"capivasertib","entityName":"Capivasertib","entityKind":"drug","route":"/drugs/capivasertib/","file":"src/data/drugs.ts","line":609,"editUrl":"https://github.com/judegomila/OnCo/blob/main/src/data/drugs.ts#L609","field":"regulatoryEvents","current":"2 events; none dated 2026-06-12","proposed":"{ date: \"2026-06-12\", type: \"approval\", region: \"US\", note: \"approves capivasertib with abiraterone and prednisone for PTEN-deficient androgen pathway modulation-naïve or -sensitive prostate cancer\", source: \"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-capivasertib-abiraterone-and-prednisone-pten-deficient-androgen-pathway-modulation\" }","evidence":"On June 12, 2026, the Food and Drug Administration approved capivasertib (Truqap, AstraZeneca) in combination with abiraterone and prednisone for adults with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer (previously referred to as metastatic hormone-sensitive p","sourceUrl":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-capivasertib-abiraterone-and-prednisone-pten-deficient-androgen-pathway-modulation","detected":"2026-09-09","id":"regulatory-event:capivasertib:regulatoryevents:-date:-2026-06-12-type:-approval-region:-us-note:-approves-capivasertib-with-abiraterone-and-prednisone-for-pten-"},{"kind":"regulatory-event","confidence":"high","entityId":"prednisone","entityName":"Prednisone","entityKind":"drug","route":"/drugs/prednisone/","file":"src/data/drugs-approved-wave1.ts","line":202,"editUrl":"https://github.com/judegomila/OnCo/blob/main/src/data/drugs-approved-wave1.ts#L202","field":"regulatoryEvents","current":"0 events; none dated 2026-06-12","proposed":"{ date: \"2026-06-12\", type: \"approval\", region: \"US\", note: \"approves capivasertib with abiraterone and prednisone for PTEN-deficient androgen pathway modulation-naïve or -sensitive prostate cancer\", source: \"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-capivasertib-abiraterone-and-prednisone-pten-deficient-androgen-pathway-modulation\" }","evidence":"On June 12, 2026, the Food and Drug Administration approved capivasertib (Truqap, AstraZeneca) in combination with abiraterone and prednisone for adults with metastatic androgen pathway modulation-naïve or -sensitive (mAPMN/S) prostate cancer (previously referred to as metastatic hormone-sensitive p","sourceUrl":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-capivasertib-abiraterone-and-prednisone-pten-deficient-androgen-pathway-modulation","detected":"2026-09-09","id":"regulatory-event:prednisone:regulatoryevents:-date:-2026-06-12-type:-approval-region:-us-note:-approves-capivasertib-with-abiraterone-and-prednisone-for-pten-de"},{"kind":"regulatory-event","confidence":"high","entityId":"pembrolizumab","entityName":"Pembrolizumab","entityKind":"drug","route":"/drugs/pembrolizumab/","file":"src/data/drugs.ts","line":236,"editUrl":"https://github.com/judegomila/OnCo/blob/main/src/data/drugs.ts#L236","field":"regulatoryEvents","current":"10 events; none dated 2026-06-12","proposed":"{ date: \"2026-06-12\", type: \"approval\", region: \"US\", note: \"approves belzutifan with pembrolizumab for adjuvant treatment of renal cell carcinoma\", source: \"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belzutifan-pembrolizumab-adjuvant-treatment-renal-cell-carcinoma\" }","evidence":"On June 12, 2026, the Food and Drug Administration approved belzutifan (Welireg, Merck & Co., Inc.) in combination with pembrolizumab (Keytruda, Merck & Co., Inc.) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck & Co., Inc.) for the adjuvant treatment of adults with renal cell","sourceUrl":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belzutifan-pembrolizumab-adjuvant-treatment-renal-cell-carcinoma","detected":"2026-09-09","id":"regulatory-event:pembrolizumab:regulatoryevents:-date:-2026-06-12-type:-approval-region:-us-note:-approves-belzutifan-with-pembrolizumab-for-adjuvant-treatment-"},{"kind":"regulatory-event","confidence":"high","entityId":"belzutifan","entityName":"Belzutifan","entityKind":"drug","route":"/drugs/belzutifan/","file":"src/data/drugs.ts","line":649,"editUrl":"https://github.com/judegomila/OnCo/blob/main/src/data/drugs.ts#L649","field":"regulatoryEvents","current":"4 events; none dated 2026-06-12","proposed":"{ date: \"2026-06-12\", type: \"approval\", region: \"US\", note: \"approves belzutifan with pembrolizumab for adjuvant treatment of renal cell carcinoma\", source: \"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belzutifan-pembrolizumab-adjuvant-treatment-renal-cell-carcinoma\" }","evidence":"On June 12, 2026, the Food and Drug Administration approved belzutifan (Welireg, Merck & Co., Inc.) in combination with pembrolizumab (Keytruda, Merck & Co., Inc.) or pembrolizumab and berahyaluronidase alfa-pmph (Keytruda Qlex, Merck & Co., Inc.) for the adjuvant treatment of adults with renal cell","sourceUrl":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-belzutifan-pembrolizumab-adjuvant-treatment-renal-cell-carcinoma","detected":"2026-09-09","id":"regulatory-event:belzutifan:regulatoryevents:-date:-2026-06-12-type:-approval-region:-us-note:-approves-belzutifan-with-pembrolizumab-for-adjuvant-treatment-of-"},{"kind":"regulatory-event","confidence":"high","entityId":"durvalumab","entityName":"Durvalumab","entityKind":"drug","route":"/drugs/durvalumab/","file":"src/data/drugs.ts","line":286,"editUrl":"https://github.com/judegomila/OnCo/blob/main/src/data/drugs.ts#L286","field":"regulatoryEvents","current":"9 events; none dated 2026-05-28","proposed":"{ date: \"2026-05-28\", type: \"approval\", region: \"US\", note: \"approves durvalumab in combination with Bacillus Calmette-Guerin for high-risk non-muscle invasive bladder cancer\", source: \"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-combination-bacillus-calmette-guerin-high-risk-non-muscle-invasive-bladder\" }","evidence":"On May 28, 2026, the Food and Drug Administration approved durvalumab (Imfinzi, AstraZeneca) in combination with Bacillus Calmette-Guerin (BCG) for the treatment of adult patients with BCG-naïve, high-risk non-muscle invasive bladder cancer (NMIBC).","sourceUrl":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-durvalumab-combination-bacillus-calmette-guerin-high-risk-non-muscle-invasive-bladder","detected":"2026-09-09","id":"regulatory-event:durvalumab:regulatoryevents:-date:-2026-05-28-type:-approval-region:-us-note:-approves-durvalumab-in-combination-with-bacillus-calmette-guerin-"},{"kind":"regulatory-event","confidence":"high","entityId":"pivekimab-sunirine","entityName":"Pivekimab sunirine","entityKind":"drug","route":"/drugs/pivekimab-sunirine/","file":"src/data/gap-fill.ts","line":178,"editUrl":"https://github.com/judegomila/OnCo/blob/main/src/data/gap-fill.ts#L178","field":"regulatoryEvents","current":"0 events; none dated 2026-05-27","proposed":"{ date: \"2026-05-27\", type: \"approval\", region: \"US\", note: \"approves pivekimab sunirine-pvzy for blastic plasmacytoid dendritic cell neoplasm, an ultra-rare hematologic malignancy\", source: \"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pivekimab-sunirine-pvzy-blastic-plasmacytoid-dendritic-cell-neoplasm-ultra-rare\" }","evidence":"On May 27, 2026, the Food and Drug Administration approved pivekimab sunirine-pvzy (Decnupaz, AbbVie, Inc.), a CD123-directed antibody and alkylating agent conjugate, for adults with blastic plasmacytoid dendritic cell neoplasm (BPDCN).","sourceUrl":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pivekimab-sunirine-pvzy-blastic-plasmacytoid-dendritic-cell-neoplasm-ultra-rare","detected":"2026-09-09","id":"regulatory-event:pivekimab-sunirine:regulatoryevents:-date:-2026-05-27-type:-approval-region:-us-note:-approves-pivekimab-sunirine-pvzy-for-blastic-plasmacytoid"},{"kind":"regulatory-event","confidence":"high","entityId":"datopotamab-deruxtecan","entityName":"Datopotamab deruxtecan","entityKind":"drug","route":"/drugs/datopotamab-deruxtecan/","file":"src/data/drugs.ts","line":41,"editUrl":"https://github.com/judegomila/OnCo/blob/main/src/data/drugs.ts#L41","field":"regulatoryEvents","current":"4 events; none dated 2026-05-22","proposed":"{ date: \"2026-05-22\", type: \"approval\", region: \"US\", note: \"approves datopotamab deruxtecan-dlnk for unresectable or metastatic triple-negative breast cancer\", source: \"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-triple-negative-breast-cancer\" }","evidence":"On May 22, 2026, the Food and Drug Administration approved datopotamab deruxtecan-dlnk (Datroway, Daiichi Sankyo, Inc.) for adult patients with unresectable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitor therapy.","sourceUrl":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-datopotamab-deruxtecan-dlnk-unresectable-or-metastatic-triple-negative-breast-cancer","detected":"2026-09-09","id":"regulatory-event:datopotamab-deruxtecan:regulatoryevents:-date:-2026-05-22-type:-approval-region:-us-note:-approves-datopotamab-deruxtecan-dlnk-for-unresectable"},{"kind":"trial-status","confidence":"medium","entityId":"tower","entityName":"TOWER","entityKind":"trial","route":"/trials/tower/","file":"src/data/spikes/all-leukemia.ts","line":114,"editUrl":"https://github.com/judegomila/OnCo/blob/main/src/data/spikes/all-leukemia.ts#L114","field":"status","current":"positive","proposed":"withdrawn","evidence":"ClinicalTrials.gov overall status is TERMINATED; recorded positive. Editorial statuses (positive, negative, mixed) need the result, so this is a floor, not a verdict.","sourceUrl":"https://clinicaltrials.gov/study/NCT02013167","id":"trial-status:tower:status:withdrawn","detected":"2026-09-17"},{"kind":"drug-approval","confidence":"medium","entityId":"givinostat","entityName":"Givinostat","entityKind":"drug","route":"/drugs/givinostat/","file":"src/data/drugs-pipeline-wave1.ts","line":541,"editUrl":"https://github.com/judegomila/OnCo/blob/main/src/data/drugs-pipeline-wave1.ts#L541","field":"approvals / status","current":"status phase-3; no US approval recorded","proposed":"add { region: \"US\", year: <from label>, indication: <from label> } and set status to approved","evidence":"openFDA has a label for \"Givinostat\"","sourceUrl":"https://open.fda.gov/apis/drug/label/","id":"drug-approval:givinostat:approvals-status:add-region:-us-year:-from-label-indication:-from-label-and-set-status-to-approved","detected":"2026-09-17"},{"kind":"trial-completion","confidence":"medium","entityId":"nct05186974","entityName":"Study of Sacituzumab Govitecan Combinations in First-line Treatment of Participants With Advanced or Metastatic Non-Small-Cell Lung Cancer (NSCLC)","entityKind":"trial","route":"/trials/nct05186974/","file":"src/data/pipeline-trials-wave5.ts","line":3600,"editUrl":"https://github.com/judegomila/OnCo/blob/main/src/data/pipeline-trials-wave5.ts#L3600","field":"yearReported / calendar","current":"2026-09","proposed":"2027-03","evidence":"Primary completion date moved from 2026-09 to 2027-03; check the readout calendar entry.","sourceUrl":"https://clinicaltrials.gov/study/NCT05186974","detected":"2026-09-11","id":"trial-completion:nct05186974:yearreported-calendar:2027-03"},{"kind":"trial-completion","confidence":"medium","entityId":"nct05201248","entityName":"A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab As Monotherapy or Combined With Standard of Care Th","entityKind":"trial","route":"/trials/nct05201248/","file":"src/data/pipeline-trials-wave5.ts","line":1710,"editUrl":"https://github.com/judegomila/OnCo/blob/main/src/data/pipeline-trials-wave5.ts#L1710","field":"yearReported / calendar","current":"2025-04","proposed":"2026-09","evidence":"Primary completion date moved from 2025-04 to 2026-09; check the readout calendar entry.","sourceUrl":"https://clinicaltrials.gov/study/NCT05201248","detected":"2026-09-11","id":"trial-completion:nct05201248:yearreported-calendar:2026-09"},{"kind":"new-product","confidence":"medium","entityName":"FDA approves allogeneic regulatory T cell-based immunotherapy with HSPC and T cells-vldq for use in matched donor hematopoietic stem cell transplantation for adults with hematologic malignancies","field":"new drug record","current":"(not in corpus)","proposed":"add product (see notice) with a US approval dated 2026-06-30","evidence":"FDA approves allogeneic regulatory T cell-based immunotherapy with HSPC and T cells-vldq for use in matched donor hematopoietic stem cell transplantation for adults with hematologic malignancies","sourceUrl":"https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-allogeneic-regulatory-t-cell-based-immunotherapy-hspc-and-t-cells-vldq-use-matched","detected":"2026-09-09","id":"new-product:fda-approves-allogeneic-regulatory-t-cell-based-immunotherapy-with-hspc-and-t-cells-vldq-for-use-in-matched-donor-hematopoietic-stem-cell-transplant"},{"kind":"trial-status","confidence":"low","entityId":"alkove-1","entityName":"ALKOVE-1","entityKind":"trial","route":"/trials/alkove-1/","file":"src/data/spikes/nsclc.ts","line":120,"editUrl":"https://github.com/judegomila/OnCo/blob/main/src/data/spikes/nsclc.ts#L120","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/NCT05384626","id":"trial-status:alkove-1:status:recruiting","detected":"2026-09-17"},{"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":"2026-09-17"},{"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":"2026-09-17"},{"kind":"trial-status","confidence":"low","entityId":"harmoni-3","entityName":"HARMONi-3","entityKind":"trial","route":"/trials/harmoni-3/","file":"src/data/spikes/nsclc.ts","line":73,"editUrl":"https://github.com/judegomila/OnCo/blob/main/src/data/spikes/nsclc.ts#L73","field":"status","current":"mixed","proposed":"recruiting","evidence":"ClinicalTrials.gov overall status is RECRUITING; recorded mixed. Editorial statuses (positive, negative, mixed) need the result, so this is a floor, not a verdict.","sourceUrl":"https://clinicaltrials.gov/study/NCT05899608","id":"trial-status:harmoni-3:status:recruiting","detected":"2026-09-17"},{"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":"2026-09-17"},{"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":"2026-09-17"},{"kind":"trial-status","confidence":"low","entityId":"niche-2","entityName":"NICHE-2","entityKind":"trial","route":"/trials/niche-2/","file":"src/data/spikes/colorectal.ts","line":51,"editUrl":"https://github.com/judegomila/OnCo/blob/main/src/data/spikes/colorectal.ts#L51","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/NCT03026140","id":"trial-status:niche-2:status:recruiting","detected":"2026-09-17"},{"kind":"trial-status","confidence":"low","entityId":"hr-nbl1","entityName":"SIOPEN HR-NBL1","entityKind":"trial","route":"/trials/hr-nbl1/","file":"src/data/spikes/neuroblastoma.ts","line":129,"editUrl":"https://github.com/judegomila/OnCo/blob/main/src/data/spikes/neuroblastoma.ts#L129","field":"status","current":"mixed","proposed":"recruiting","evidence":"ClinicalTrials.gov overall status is RECRUITING; recorded mixed. Editorial statuses (positive, negative, mixed) need the result, so this is a floor, not a verdict.","sourceUrl":"https://clinicaltrials.gov/study/NCT01704716","id":"trial-status:hr-nbl1:status:recruiting","detected":"2026-09-17"},{"kind":"trial-status","confidence":"low","entityId":"soho-01","entityName":"SOHO-01","entityKind":"trial","route":"/trials/soho-01/","file":"src/data/spikes/nsclc.ts","line":126,"editUrl":"https://github.com/judegomila/OnCo/blob/main/src/data/spikes/nsclc.ts#L126","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/NCT05099172","id":"trial-status:soho-01:status:recruiting","detected":"2026-09-17"}]}