{"entity":{"id":"inotuzumab-ozogamicin","kind":"drug","name":"Inotuzumab ozogamicin","aka":[],"tldr":"Inotuzumab ozogamicin is an antibody carrying a DNA-cutting toxin to CD22 on leukaemia cells. It gets far more relapsed ALL patients into remission than chemotherapy and bridges them to transplant.","summary":"INO-VATE (n=326): CR/CRi 80.7% vs 29.4% vs standard chemotherapy, more MRD-negative remissions and transplants; OS 7.7 vs 6.7 months (HR 0.77), statistically significant on the 2-year landmark. Approved 2017 (adults); paediatric approval 2024 (ITCC-059). Hepatic veno-occlusive disease after transplant (boxed warning) is mitigated by limiting cycles and avoiding dual-alkylator conditioning. Moving frontline for older adults (ALLIANCE A041501; Mini-hyper-CVD + InO) and children (COG AALL1732).","status":"approved","asOf":"2026-09-07","wikipedia":"https://en.wikipedia.org/wiki/Inotuzumab_ozogamicin","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Inotuzumab%20ozogamicin"}],"tags":[],"related":["cd22-expression"],"cancers":["all-leukemia","all-paediatric-relapsed","all-paediatric-high-risk"],"sections":[],"technologies":["adc"],"targets":["cd22"],"drugs":[],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":["payload","linker"],"trials":["ino-vate","nct05748171"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Besponsa","modality":"ADC","payload":"Calicheamicin (DNA-cleaving enediyne), DAR ~6","linker":"Acid-labile hydrazone (AcBut)","mechanism":"Humanised anti-CD22 IgG4 internalises; acid-cleaved calicheamicin binds the DNA minor groove and causes double-strand breaks.","approvals":[{"region":"US","year":2017,"indication":"Relapsed/refractory CD22+ B-ALL, adults"},{"region":"US","year":2024,"indication":"Paediatric patients ≥1 year with relapsed/refractory CD22+ B-ALL"}],"mechanismSteps":["Antibody binds CD22 on the B-lymphoblast","The complex is rapidly internalised into acidic endosomes","The hydrazone linker hydrolyses and releases calicheamicin","Calicheamicin binds the DNA minor groove and cleaves both strands","The blast dies; bystander effect is limited because free calicheamicin is short-lived"],"dosing":{"route":"IV over 1 hour","schedule":"Cycle 1: 0.8 mg/m² day 1, 0.5 mg/m² days 8 and 15 (21-day cycle); subsequent cycles 0.5 mg/m² days 1, 8, 15; limit to 2 cycles if proceeding to transplant, maximum 6","monitoring":"Liver enzymes and bilirubin (VOD boxed warning), counts, QT","source":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Besponsa"},"toxicity":[{"event":"Hepatic veno-occlusive disease","anyGradePct":14,"source":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Besponsa","note":"Boxed warning; 22% of those who went on to transplant in INO-VATE"},{"event":"Thrombocytopenia","grade3PlusPct":41},{"event":"Febrile neutropenia","grade3PlusPct":27},{"event":"Transaminase elevation","anyGradePct":27}],"access":[],"regulatoryEvents":[{"date":"2017-08-17","type":"approval","region":"US","note":"INO-VATE"},{"date":"2024-03-06","type":"label-change","region":"US","note":"Paediatric expansion"}]},"route":"/drugs/inotuzumab-ozogamicin/","neighbours":{"biomarker":[{"id":"cd22-expression","kind":"biomarker","name":"CD22 expression (CD22-positive)","route":"/biomarkers/cd22-expression/"}],"cancer":[{"id":"all-leukemia","kind":"cancer","name":"Acute lymphoblastic leukaemia","route":"/cancers/all-leukemia/"},{"id":"all-paediatric-high-risk","kind":"cancer","name":"High-risk acute lymphoblastic leukaemia in children (high-risk B-ALL and T-ALL)","route":"/cancers/all-paediatric-high-risk/"},{"id":"all-paediatric-ph-positive","kind":"cancer","name":"Philadelphia chromosome-positive acute lymphoblastic leukaemia in children (Ph-positive ALL)","route":"/cancers/all-paediatric-ph-positive/"},{"id":"all-paediatric-relapsed","kind":"cancer","name":"Relapsed and refractory acute lymphoblastic leukaemia in children","route":"/cancers/all-paediatric-relapsed/"},{"id":"all-paediatric-standard-risk","kind":"cancer","name":"Standard-risk B-cell acute lymphoblastic leukaemia in children","route":"/cancers/all-paediatric-standard-risk/"}],"technology":[{"id":"adc","kind":"technology","name":"Antibody-drug conjugate (ADC)","route":"/technologies/adc/"}],"target":[{"id":"cd22","kind":"target","name":"CD22","route":"/targets/cd22/"}],"company":[{"id":"pfizer","kind":"company","name":"Pfizer (incl. Seagen)","route":"/companies/pfizer/"}],"term":[{"id":"linker","kind":"term","name":"Linker (ADC)","route":"/terms/linker/"},{"id":"payload","kind":"term","name":"Payload (ADC)","route":"/terms/payload/"}],"trial":[{"id":"nct05748171","kind":"trial","name":"A Study to Learn More About the Study Medicine Called Inotuzumab Ozogamicin (InO) in Children (1 to <18 Years) With First Relapse ALL","route":"/trials/nct05748171/"},{"id":"ino-vate","kind":"trial","name":"INO-VATE ALL","route":"/trials/ino-vate/"},{"id":"nct03150693","kind":"trial","name":"Inotuzumab Ozogamicin and Frontline Chemotherapy in Treating Young Adults With Newly Diagnosed B Acute Lymphoblastic Leukemia","route":"/trials/nct03150693/"}],"pairing":[{"id":"inotuzumab-then-transplant-caution","kind":"pairing","name":"Caution: inotuzumab before transplant (veno-occlusive disease)","route":"/pairings/inotuzumab-then-transplant-caution/"}],"paper":[{"id":"paper-ino-vate-inotuzumab-all-nejm-2016","kind":"paper","name":"INO-VATE: inotuzumab ozogamicin, a CD22 antibody-drug conjugate, versus chemotherapy for relapsed adult B-cell ALL","route":"/key-papers/paper-ino-vate-inotuzumab-all-nejm-2016/"}]}}