{"entity":{"id":"blinatumomab","kind":"drug","name":"Blinatumomab","aka":[],"tldr":"Blinatumomab was the first T-cell engager (2014), and is now given to children and adults with leukaemia even when in remission, because it improves survival.","summary":"Blinatumomab is a bispecific T-cell engager (BiTE) built from two tandem single-chain antibody fragments, one binding CD19 on B-lineage leukaemia cells and the other binding CD3 on T cells, so any T cell can be redirected to kill the leukaemia cell without MHC presentation. Its half-life is about 2 hours, so it is given by continuous intravenous infusion in 42-day cycles; a subcutaneous formulation is in development. Approved in 2014 as the first BiTE for relapsed or refractory B-ALL, it became the first drug approved on a minimal residual disease endpoint in 2018, and in 2024 was approved as consolidation for CD19-positive B-ALL regardless of MRD after E1910 showed an overall survival benefit in adults and AALL1731 in children. Neurological toxicity occurred in 65 percent of relapsed adults and cytokine release syndrome in 14 percent, so early cycle days are spent in hospital.","status":"approved","asOf":"2026-09-04","wikipedia":"https://en.wikipedia.org/wiki/Blinatumomab","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Blinatumomab"}],"tags":[],"related":["cd19-expression"],"cancers":["all-leukemia","all-paediatric-standard-risk","all-paediatric-relapsed","all-infant"],"sections":[],"technologies":["t-cell-engager"],"targets":["cd19","cd3"],"drugs":[],"companies":["amgen"],"institutions":[],"pathways":[],"terms":[],"trials":["nct04521231","nct07134088","nct07387926"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Blincyto","modality":"Bispecific T-cell engager (CD19×CD3)","mechanism":"Tandem scFv BiTE.","approvals":[{"region":"US","year":2014,"indication":"Relapsed/refractory B-ALL"},{"region":"US","year":2024,"indication":"Consolidation in CD19+ B-ALL regardless of MRD"}],"mechanismSteps":["One arm binds CD19 on the tumour cell","The other arm binds CD3 on any passing T cell","An artificial immune synapse forms, independent of MHC","The T cell releases perforin and granzymes into the tumour cell","Tumour cell dies; cytokines are released (source of CRS)"],"dosing":{"route":"Continuous IV infusion","schedule":"Adults: 9 µg/day days 1-7 then 28 µg/day to day 28, 14-day break; 42-day cycles; weight-based in children","modifications":"Interrupt for grade 3 CRS or neurotoxicity; dexamethasone premedication","monitoring":"Hospitalisation for first 9 days of cycle 1 and first 2 days of cycle 2; neurological exams; infection surveillance","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=38b482a8-960b-4591-9857-5031ecb830aa"},"toxicity":[{"event":"Neurological toxicities","anyGradePct":65,"grade3PlusPct":13,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=38b482a8-960b-4591-9857-5031ecb830aa","note":"Relapsed/refractory adult ALL"},{"event":"Pyrexia","anyGradePct":55,"grade3PlusPct":6,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=38b482a8-960b-4591-9857-5031ecb830aa","note":"Relapsed/refractory adult ALL"},{"event":"Febrile neutropenia","anyGradePct":31,"grade3PlusPct":28,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=38b482a8-960b-4591-9857-5031ecb830aa","note":"Relapsed/refractory adult ALL"},{"event":"Infections","anyGradePct":28,"grade3PlusPct":15,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=38b482a8-960b-4591-9857-5031ecb830aa","note":"Relapsed/refractory adult ALL"},{"event":"Cytokine release syndrome","anyGradePct":14,"grade3PlusPct":3,"source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=38b482a8-960b-4591-9857-5031ecb830aa","note":"Relapsed/refractory adult ALL"},{"event":"Infusion-related reactions","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=38b482a8-960b-4591-9857-5031ecb830aa","note":"Relapsed/refractory adult ALL"},{"event":"Headache","source":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=38b482a8-960b-4591-9857-5031ecb830aa","note":"Relapsed/refractory adult ALL"}],"access":[{"country":"US","reimbursement":"Medicare Part B (physician-administered); commercial plans per formulary","assistance":"https://www.amgensupportplus.com","source":"https://www.cms.gov/medicare/payment/part-b-drugs/asp-pricing-files","asOf":"2026-09-06"},{"country":"UK","reimbursement":"NICE: recommended in Ph-negative relapsed/refractory B-ALL (TA450) and MRD-positive ALL (TA589)","source":"https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance","asOf":"2026-09-06"}],"regulatoryEvents":[{"date":"2014-12-03","type":"accelerated-approval","region":"US","note":"Accelerated approval, Ph-negative relapsed/refractory B-ALL: first BiTE","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications","indication":"Philadelphia chromosome negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia"},{"date":"2017-07-11","type":"conversion","region":"US","note":"Full approval including Ph+ ALL","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications","indication":"Philadelphia chromosome negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia"},{"date":"2018-03-29","type":"accelerated-approval","region":"US","note":"MRD-positive B-ALL: first approval based on MRD","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications","indication":"Treatment of CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1% in adults and children 1"},{"date":"2023-06-20","type":"conversion","region":"US","note":"Confirmed: the accelerated approval of 2018 converted to traditional approval 5.2 years after it was granted.","source":"https://www.fda.gov#footnote1_815g9a4","indication":"Treatment of CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1% in adults and children 1"},{"date":"2024-06-14","type":"approval","region":"US","note":"Consolidation in CD19+ Ph-negative B-ALL regardless of MRD (E1910)","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"}]},"route":"/drugs/blinatumomab/","neighbours":{"biomarker":[{"id":"cd19-expression","kind":"biomarker","name":"CD19 expression (CD19-positive)","route":"/biomarkers/cd19-expression/"}],"cancer":[{"id":"all-leukemia","kind":"cancer","name":"Acute lymphoblastic leukaemia","route":"/cancers/all-leukemia/"},{"id":"aya-cancers","kind":"cancer","name":"Adolescent and young adult cancers (ages 15 to 39)","route":"/cancers/aya-cancers/"},{"id":"childhood-cancers","kind":"cancer","name":"Childhood cancers (all types)","route":"/cancers/childhood-cancers/"},{"id":"cml-advanced-phase","kind":"cancer","name":"Chronic myeloid leukaemia, accelerated and blast phase","route":"/cancers/cml-advanced-phase/"},{"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-infant","kind":"cancer","name":"Infant acute lymphoblastic leukaemia (KMT2A-rearranged, under one year)","route":"/cancers/all-infant/"},{"id":"mixed-phenotype-acute-leukaemia","kind":"cancer","name":"Mixed-phenotype acute leukaemia","route":"/cancers/mixed-phenotype-acute-leukaemia/"},{"id":"all-ph-like","kind":"cancer","name":"Philadelphia chromosome-like acute lymphoblastic leukaemia (Ph-like or BCR::ABL1-like ALL)","route":"/cancers/all-ph-like/"},{"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":"t-cell-engager","kind":"technology","name":"T-cell engagers (bispecific)","route":"/technologies/t-cell-engager/"}],"target":[{"id":"cd19","kind":"target","name":"CD19","route":"/targets/cd19/"},{"id":"cd3","kind":"target","name":"CD3","route":"/targets/cd3/"}],"company":[{"id":"amgen","kind":"company","name":"Amgen","route":"/companies/amgen/"},{"id":"childrens-oncology-group","kind":"company","name":"Children's Oncology Group (COG)","route":"/companies/childrens-oncology-group/"},{"id":"ecog-acrin","kind":"company","name":"ECOG-ACRIN Cancer Research Group","route":"/companies/ecog-acrin/"},{"id":"gimema","kind":"company","name":"GIMEMA","route":"/companies/gimema/"}],"trial":[{"id":"nct04521231","kind":"trial","name":"A Study of Subcutaneous Blinatumomab Administration in Participants With R/R and MRD+ B-ALL","route":"/trials/nct04521231/"},{"id":"nct07134088","kind":"trial","name":"A Study of Subcutaneous Blinatumomab in Children With R/R and and MRD+ B-Cell Precursor Acute Lymphoblastic Leukemia","route":"/trials/nct07134088/"},{"id":"aall1331","kind":"trial","name":"AALL1331","route":"/trials/aall1331/"},{"id":"aall1731","kind":"trial","name":"COG AALL1731","route":"/trials/aall1731/"},{"id":"d-alba","kind":"trial","name":"D-ALBA (GIMEMA LAL2116)","route":"/trials/d-alba/"},{"id":"e1910","kind":"trial","name":"ECOG-ACRIN E1910","route":"/trials/e1910/"},{"id":"interfant-06","kind":"trial","name":"Interfant-06","route":"/trials/interfant-06/"},{"id":"intreall-sr-2010","kind":"trial","name":"IntReALL SR 2010","route":"/trials/intreall-sr-2010/"},{"id":"nct07387926","kind":"trial","name":"Safety and Efficacy of Asciminib in Pediatrics and Young Adults With Relapse/Refractory (r/r) Philadelphia Positive (Ph+) or ABL-class Ph-like Acute Lymphoblastic Leukemia (ALL)","route":"/trials/nct07387926/"},{"id":"tower","kind":"trial","name":"TOWER","route":"/trials/tower/"}],"term":[{"id":"b-all-cytogenetic-risk","kind":"term","name":"B-ALL risk groups (NCI criteria, ETV6::RUNX1, hyperdiploidy, hypodiploidy, iAMP21, IKZF1, CNS status)","route":"/terms/b-all-cytogenetic-risk/"},{"id":"abl1-kinase-domain-mutations","kind":"term","name":"BCR::ABL1 kinase domain mutations (T315I and others)","route":"/terms/abl1-kinase-domain-mutations/"},{"id":"leukaemia-type","kind":"term","name":"Leukaemia (tissue type)","route":"/terms/leukaemia-type/"},{"id":"ph-like-all","kind":"term","name":"Ph-like (BCR::ABL1-like) acute lymphoblastic leukaemia","route":"/terms/ph-like-all/"},{"id":"ph-positive-all","kind":"term","name":"Ph-positive ALL","route":"/terms/ph-positive-all/"},{"id":"philadelphia-chromosome","kind":"term","name":"Philadelphia chromosome (Ph+, BCR::ABL1)","route":"/terms/philadelphia-chromosome/"},{"id":"umrd","kind":"term","name":"Undetectable MRD (uMRD / MRD-negative)","route":"/terms/umrd/"}],"pairing":[{"id":"tki-plus-blinatumomab-ph-all","kind":"pairing","name":"BCR::ABL1 TKI + blinatumomab (chemotherapy-free Ph+ ALL)","route":"/pairings/tki-plus-blinatumomab-ph-all/"},{"id":"blinatumomab-frontline-consolidation","kind":"pairing","name":"Blinatumomab added to frontline chemotherapy","route":"/pairings/blinatumomab-frontline-consolidation/"}],"idea":[{"id":"idea-menin-infant-all","kind":"idea","name":"Menin inhibitors for infant KMT2A-rearranged ALL","route":"/ideas/idea-menin-infant-all/"},{"id":"idea-transplant-free-ph-all","kind":"idea","name":"Transplant-free Ph-positive ALL for MRD-negative adults","route":"/ideas/idea-transplant-free-ph-all/"}],"roadmap":[{"id":"cell-therapy-roadmap","kind":"roadmap","name":"Cell therapy roadmap: CD19 CAR-T → solid tumours → in vivo CAR","route":"/roadmaps/cell-therapy-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/"}],"person":[{"id":"elias-jabbour","kind":"person","name":"Elias Jabbour","route":"/people/elias-jabbour/"},{"id":"hagop-kantarjian","kind":"person","name":"Hagop M. Kantarjian","route":"/people/hagop-kantarjian/"},{"id":"mark-litzow","kind":"person","name":"Mark R. Litzow","route":"/people/mark-litzow/"},{"id":"nicola-gokbuget","kind":"person","name":"Nicola Gökbuget","route":"/people/nicola-gokbuget/"},{"id":"rachel-rau","kind":"person","name":"Rachel E. Rau","route":"/people/rachel-rau/"},{"id":"stephen-hunger","kind":"person","name":"Stephen P. Hunger","route":"/people/stephen-hunger/"},{"id":"sumit-gupta","kind":"person","name":"Sumit Gupta","route":"/people/sumit-gupta/"}],"paper":[{"id":"paper-aall1331-low-risk-hogan-jco-2023","kind":"paper","name":"AALL1331: blinatumomab added to chemotherapy in low-risk first relapse of childhood B-ALL","route":"/key-papers/paper-aall1331-low-risk-hogan-jco-2023/"},{"id":"paper-aall1331-brown-jama-2021","kind":"paper","name":"AALL1331: blinatumomab versus chemotherapy consolidation in high- and intermediate-risk first relapse of childhood B-ALL","route":"/key-papers/paper-aall1331-brown-jama-2021/"},{"id":"paper-blinatumomab-infant-all-van-der-sluis-nejm-2023","kind":"paper","name":"Blinatumomab added to chemotherapy in infant KMT2A-rearranged acute lymphoblastic leukaemia","route":"/key-papers/paper-blinatumomab-infant-all-van-der-sluis-nejm-2023/"},{"id":"paper-aall1731-blinatumomab-children-nejm-2025","kind":"paper","name":"Children's Oncology Group AALL1731: blinatumomab added to chemotherapy for children with standard-risk B-cell ALL","route":"/key-papers/paper-aall1731-blinatumomab-children-nejm-2025/"},{"id":"paper-e1910-blinatumomab-mrd-negative-all-nejm-2024","kind":"paper","name":"ECOG-ACRIN E1910: adding blinatumomab to chemotherapy for adults with B-cell ALL already in MRD-negative remission","route":"/key-papers/paper-e1910-blinatumomab-mrd-negative-all-nejm-2024/"},{"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/"}]}}