{"entity":{"id":"dinutuximab","kind":"drug","name":"Dinutuximab (ch14.18) / dinutuximab beta","aka":[],"tldr":"The antibody that raised cure rates in high-risk childhood neuroblastoma by about 20 points when given after transplant with immune boosters and retinoid.","summary":"ANBL0032: ch14.18 + GM-CSF + IL-2 + isotretinoin vs isotretinoin: 2-year EFS 66% vs 46%, OS 86% vs 75%; approved March 2015 (United Therapeutics). Dinutuximab beta (SIOPEN/EUSA/Recordati) approved in EU 2017; HR-NBL1 showed adding IL-2 to dinutuximab beta added toxicity without benefit, so IL-2 is omitted in Europe. Now also given with chemotherapy for relapse (ANBL1221: irinotecan-temozolomide-dinutuximab ORR ~50%) and during induction (ANBL17P1).","status":"approved","asOf":"2026-09-07","wikipedia":"https://en.wikipedia.org/wiki/Dinutuximab","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Dinutuximab/%20dinutuximab%20beta"}],"tags":[],"related":[],"cancers":["neuroblastoma","neuroblastoma-high-risk"],"sections":[],"technologies":["monoclonal-antibody"],"targets":["gd2"],"drugs":[],"companies":["united-therapeutics"],"institutions":[],"pathways":[],"terms":["adcc"],"trials":["anbl0032","hr-nbl1"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Unituxin / Qarziba (EU)","modality":"Monoclonal antibody (anti-GD2, chimeric)","mechanism":"Chimeric IgG1 anti-GD2; ADCC (NK cells, granulocytes with GM-CSF) and CDC against GD2+ cells; neuropathic pain from binding to peripheral nerve GD2.","approvals":[{"region":"US","year":2015,"indication":"High-risk neuroblastoma after at least partial response to induction, with GM-CSF, IL-2 and isotretinoin"},{"region":"EU","year":2017,"indication":"Dinutuximab beta: high-risk neuroblastoma after induction/transplant; relapsed/refractory disease"}],"mechanismSteps":["Antibody binds GD2 on the neuroblastoma cell surface","Fc region recruits NK cells and neutrophils (ADCC) and complement (CDC)","GM-CSF (and formerly IL-2) expands effector cells","Tumour cells lyse; peripheral nerves also bind antibody, causing pain"],"dosing":{"route":"IV","schedule":"17.5 mg/m2/day × 4 days per cycle, 5 cycles, with GM-CSF (cycles 1, 3, 5) and isotretinoin; IL-2 omitted in European practice","modifications":"Hold for grade 3-4 infusion reactions, capillary leak, neuropathy","monitoring":"Pain management (opioids, gabapentin), hypotension, capillary leak, infusion reactions, neuropathy, electrolytes"},"toxicity":[{"event":"Neuropathic pain","anyGradePct":85,"grade3PlusPct":52,"note":"ANBL0032 immunotherapy arm"},{"event":"Infusion reactions","grade3PlusPct":25},{"event":"Capillary leak syndrome","grade3PlusPct":23},{"event":"Hypokalaemia","grade3PlusPct":35}],"access":[],"regulatoryEvents":[{"date":"2015-03-10","type":"approval","region":"US","note":"Unituxin (ANBL0032)"},{"date":"2017-05","type":"approval","region":"EU","note":"Dinutuximab beta (Qarziba)"}]},"route":"/drugs/dinutuximab/","neighbours":{"cancer":[{"id":"childhood-cancers","kind":"cancer","name":"Childhood cancers (all types)","route":"/cancers/childhood-cancers/"},{"id":"neuroblastoma-high-risk","kind":"cancer","name":"High-risk neuroblastoma","route":"/cancers/neuroblastoma-high-risk/"},{"id":"neuroblastoma","kind":"cancer","name":"Neuroblastoma (paediatric)","route":"/cancers/neuroblastoma/"}],"technology":[{"id":"monoclonal-antibody","kind":"technology","name":"Monoclonal antibodies","route":"/technologies/monoclonal-antibody/"}],"target":[{"id":"gd2","kind":"target","name":"GD2 (disialoganglioside)","route":"/targets/gd2/"}],"company":[{"id":"partner-therapeutics","kind":"company","name":"Partner Therapeutics","route":"/companies/partner-therapeutics/"},{"id":"united-therapeutics","kind":"company","name":"United Therapeutics","route":"/companies/united-therapeutics/"}],"term":[{"id":"adcc","kind":"term","name":"ADCC (antibody-dependent cellular cytotoxicity)","route":"/terms/adcc/"},{"id":"curie-siopen-score","kind":"term","name":"MIBG Curie and SIOPEN scores","route":"/terms/curie-siopen-score/"},{"id":"segmental-chromosomal-aberrations","kind":"term","name":"Segmental chromosomal aberrations and ploidy (neuroblastoma)","route":"/terms/segmental-chromosomal-aberrations/"}],"trial":[{"id":"anbl1221","kind":"trial","name":"ANBL1221","route":"/trials/anbl1221/"},{"id":"anbl17p1","kind":"trial","name":"ANBL17P1","route":"/trials/anbl17p1/"},{"id":"anbl0032","kind":"trial","name":"COG ANBL0032","route":"/trials/anbl0032/"},{"id":"nct04221035","kind":"trial","name":"High-Risk Neuroblastoma Study 2 of SIOP-Europa-Neuroblastoma (SIOPEN)","route":"/trials/nct04221035/"},{"id":"hr-nbl1","kind":"trial","name":"SIOPEN HR-NBL1","route":"/trials/hr-nbl1/"}],"pairing":[{"id":"anti-gd2-plus-chemo-relapse","kind":"pairing","name":"Anti-GD2 antibody + irinotecan-temozolomide (chemoimmunotherapy)","route":"/pairings/anti-gd2-plus-chemo-relapse/"},{"id":"il2-anti-gd2-caution","kind":"pairing","name":"Caution: IL-2 added to anti-GD2 therapy","route":"/pairings/il2-anti-gd2-caution/"}],"person":[{"id":"alice-yu","kind":"person","name":"Alice L. Yu","route":"/people/alice-yu/"},{"id":"julie-park","kind":"person","name":"Julie R. Park","route":"/people/julie-park/"}],"bottleneck":[{"id":"b-rare-cancers","kind":"bottleneck","name":"Rare and paediatric cancers without markets","route":"/bottlenecks/b-rare-cancers/"}],"institution":[{"id":"ucsd-moores","kind":"institution","name":"UC San Diego Moores Cancer Center","route":"/institutions/ucsd-moores/"},{"id":"uw-carbone","kind":"institution","name":"University of Wisconsin Carbone Cancer Center","route":"/institutions/uw-carbone/"}],"biomarker":[{"id":"mycn-amp","kind":"biomarker","name":"MYCN amplification","route":"/biomarkers/mycn-amp/"}],"roadmap":[{"id":"paediatric-oncology-roadmap","kind":"roadmap","name":"Paediatric oncology roadmap: cooperative-group cures → engineered immunity → drugs developed for children first","route":"/roadmaps/paediatric-oncology-roadmap/"}],"drug":[{"id":"isotretinoin","kind":"drug","name":"Isotretinoin","route":"/drugs/isotretinoin/"}],"paper":[{"id":"paper-anbl1221-expansion-dinutuximab-gm-csf-mody-jco-2020","kind":"paper","name":"ANBL1221 expansion: irinotecan, temozolomide and dinutuximab with GM-CSF in refractory or relapsed neuroblastoma","route":"/key-papers/paper-anbl1221-expansion-dinutuximab-gm-csf-mody-jco-2020/"},{"id":"paper-anbl1221-irinotecan-temozolomide-dinutuximab-mody-lancet-oncol-2017","kind":"paper","name":"ANBL1221: irinotecan-temozolomide with temsirolimus or dinutuximab in relapsed or refractory neuroblastoma","route":"/key-papers/paper-anbl1221-irinotecan-temozolomide-dinutuximab-mody-lancet-oncol-2017/"}]}}