{"entity":{"id":"glofitamab","kind":"drug","name":"Glofitamab","aka":[],"tldr":"Glofitamab is a fixed-duration bispecific for large B-cell lymphoma, with OS benefit when combined with chemotherapy.","summary":"Glofitamab is a CD20×CD3 bispecific T-cell engager in a 2:1 format, with two CD20-binding arms and one CD3 arm, that recruits any passing T cell to kill a B cell. A single 1,000 mg dose of obinutuzumab is given first to blunt cytokine release, followed by step-up doses of 2.5 mg and 10 mg, then 30 mg every 3 weeks for up to 12 cycles, so treatment is fixed in duration. Accelerated US approval in 2023 and conditional EU authorisation followed a response rate of 56 percent with complete responses in 43 percent in relapsed or refractory DLBCL after two or more lines. STARGLO then showed an overall survival benefit when glofitamab was added to GemOx in transplant-ineligible relapsed DLBCL; the combination is approved in the EU and elsewhere, but the FDA declined in 2025 citing regional heterogeneity. Cytokine release syndrome, neutropenia and infections are the main toxicities.","status":"approved","asOf":"2026-09-04","wikipedia":"https://en.wikipedia.org/wiki/Glofitamab","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Glofitamab"}],"tags":[],"related":[],"cancers":["dlbcl"],"sections":[],"technologies":["t-cell-engager"],"targets":["cd20","cd3"],"drugs":[],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":["nct04077723","nct06090539","nct05533775","nct06534437","nct03075696","nct06084936","nct06634589","nct03533283","nct06806033","nct04980222"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Columvi","modality":"Bispecific T-cell engager (CD20×CD3, 2:1)","mechanism":"2:1 CD20:CD3 format with obinutuzumab pre-treatment to mitigate CRS.","approvals":[{"region":"US","year":2023,"indication":"Relapsed/refractory DLBCL after ≥2 lines (accelerated)"}],"mechanismSteps":["One arm binds CD20 (bivalent, 2:1 format) 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":"IV infusion","schedule":"Obinutuzumab 1,000 mg on cycle 1 day 1, then glofitamab 2.5 mg day 8, 10 mg day 15, then 30 mg every 3 weeks for up to 12 cycles (fixed duration)","modifications":"Hold for grade ≥2 CRS; dexamethasone premedication","monitoring":"Hospitalisation for the first 2.5 mg dose; CRS, neurology, infections","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},"toxicity":[{"event":"Cytokine release syndrome"},{"event":"Neutropenia"},{"event":"Musculoskeletal pain"},{"event":"Rash"},{"event":"Fatigue"},{"event":"Infections"},{"event":"Tumour flare"}],"access":[{"country":"US","reimbursement":"Medicare Part B (physician-administered); commercial plans per formulary","assistance":"https://www.genentech-access.com","source":"https://www.cms.gov/medicare/payment/part-b-drugs/asp-pricing-files","asOf":"2026-09-06"},{"country":"UK","reimbursement":"NICE: recommended for relapsed/refractory DLBCL after ≥2 therapies (TA927)","source":"https://www.nice.org.uk/guidance/published?ngt=Technology%20appraisal%20guidance","asOf":"2026-09-06"}],"regulatoryEvents":[{"date":"2023-06-15","type":"accelerated-approval","region":"US","note":"Accelerated approval, relapsed/refractory DLBCL after ≥2 lines The confirmatory requirement was still open 3.3 years later, when the FDA's table was read.","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications","indication":"Relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified or large B-cell lymphoma arising from follicular lymphoma, after two or more lines of systemic therapy"},{"date":"2023-07","type":"approval","region":"EU","note":"Conditional marketing authorisation","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"},{"date":"2025-07-02","type":"crl","region":"US","note":"Complete response letter for STARGLO combination (regional heterogeneity); approved in EU","source":"https://www.fda.gov/drugs/resources-information-approved-drugs/oncology-cancer-hematologic-malignancies-approval-notifications"}]},"route":"/drugs/glofitamab/","neighbours":{"cancer":[{"id":"cll","kind":"cancer","name":"Chronic lymphocytic leukaemia","route":"/cancers/cll/"},{"id":"dlbcl","kind":"cancer","name":"Diffuse large B-cell lymphoma","route":"/cancers/dlbcl/"},{"id":"follicular-lymphoma","kind":"cancer","name":"Follicular lymphoma","route":"/cancers/follicular-lymphoma/"},{"id":"hiv-associated-lymphoma","kind":"cancer","name":"HIV-associated (AIDS-related) lymphomas","route":"/cancers/hiv-associated-lymphoma/"},{"id":"mantle-cell-lymphoma","kind":"cancer","name":"Mantle cell lymphoma","route":"/cancers/mantle-cell-lymphoma/"},{"id":"non-hodgkin-lymphoma","kind":"cancer","name":"Non-Hodgkin lymphoma (all types)","route":"/cancers/non-hodgkin-lymphoma/"},{"id":"post-transplant-lymphoproliferative-disorder","kind":"cancer","name":"Post-transplant lymphoproliferative disorder (PTLD)","route":"/cancers/post-transplant-lymphoproliferative-disorder/"},{"id":"primary-mediastinal-b-cell-lymphoma","kind":"cancer","name":"Primary mediastinal (thymic) large B-cell lymphoma","route":"/cancers/primary-mediastinal-b-cell-lymphoma/"}],"technology":[{"id":"t-cell-engager","kind":"technology","name":"T-cell engagers (bispecific)","route":"/technologies/t-cell-engager/"}],"target":[{"id":"cd20","kind":"target","name":"CD20","route":"/targets/cd20/"},{"id":"cd3","kind":"target","name":"CD3","route":"/targets/cd3/"}],"company":[{"id":"lysa","kind":"company","name":"LYSA (The Lymphoma Study Association)","route":"/companies/lysa/"},{"id":"roche-genentech","kind":"company","name":"Roche / Genentech","route":"/companies/roche-genentech/"}],"trial":[{"id":"nct03075696","kind":"trial","name":"A Dose Escalation Study of Glofitamab (RO7082859) as a Single Agent and in Combination With Obinutuzumab, Administered After a Fixed, Single Pre-treat","route":"/trials/nct03075696/"},{"id":"nct06090539","kind":"trial","name":"A Study to Assess BMS-986458 Alone and in Combination With Anti-lymphoma Agents in Relapsed/Refractory Non-Hodgkin Lymphomas","route":"/trials/nct06090539/"},{"id":"nct06084936","kind":"trial","name":"A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed/Refractory Mantle Cell Lymphoma","route":"/trials/nct06084936/"},{"id":"nct05533775","kind":"trial","name":"A Study to Evaluate Glofitamab Monotherapy and Glofitamab + Chemoimmunotherapy in Pediatric and Young Adult Participants With Relapsed/Refractory Matu","route":"/trials/nct05533775/"},{"id":"nct04980222","kind":"trial","name":"A Study to Evaluate the Safety and Efficacy of Glofitamab in Combination With Rituximab (R) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Circulating Tumor (ct)DNA High-Risk Patients With Untreated Diffuse Large B-Cell Lymphoma","route":"/trials/nct04980222/"},{"id":"nct04077723","kind":"trial","name":"A Study to Evaluate the Safety, Pharmacokinetics and Preliminary Anti-Tumor Activity of Englumafusp Alfa in Combination With Obinutuzumab and in Combi","route":"/trials/nct04077723/"},{"id":"nct06634589","kind":"trial","name":"A Study to Investigate Safety and Effectiveness of Tacabrutideg (BGB-16673) in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies","route":"/trials/nct06634589/"},{"id":"nct03533283","kind":"trial","name":"An Open-Label Phase lB/II Study of Glofitamab and Atezolizumab or Polatuzumab Vedotin in Adult Patients With Relapsed/Refractory B-Cell Non-Hodgkin's Lymphoma","route":"/trials/nct03533283/"},{"id":"nct06806033","kind":"trial","name":"Evaluate Optimization of CRS Profile for Glofit Monotherapy and Glofit+GemOx in R/R Aggressive B-NHL","route":"/trials/nct06806033/"},{"id":"nct06252675","kind":"trial","name":"Glofitamab With Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma","route":"/trials/nct06252675/"},{"id":"nct06534437","kind":"trial","name":"MEN1703 (SEL24) to Treat Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphoma (JASPIS-01)","route":"/trials/nct06534437/"},{"id":"starglo","kind":"trial","name":"STARGLO","route":"/trials/starglo/"}],"term":[{"id":"lymphoma-tx-bispecific-step-up","kind":"term","name":"CD20 bispecific antibodies: step-up dosing, fixed duration and what it is like to take one","route":"/terms/lymphoma-tx-bispecific-step-up/"},{"id":"lymphoma-tx-crs-icans","kind":"term","name":"Cytokine release syndrome and ICANS: grading and management","route":"/terms/lymphoma-tx-crs-icans/"},{"id":"lymphoma-tx-hepatitis-b-reactivation","kind":"term","name":"Hepatitis B reactivation before rituximab and other anti-CD20 antibodies","route":"/terms/lymphoma-tx-hepatitis-b-reactivation/"},{"id":"lymphoma-tx-immunoglobulin-replacement","kind":"term","name":"Immunoglobulin replacement after CAR-T, bispecifics and long anti-CD20 treatment","route":"/terms/lymphoma-tx-immunoglobulin-replacement/"},{"id":"lymphoma-type","kind":"term","name":"Lymphoma (tissue type)","route":"/terms/lymphoma-type/"},{"id":"lymphoma-tx-failed-and-negative","kind":"term","name":"Lymphoma treatments that did not work: the negative trials worth knowing","route":"/terms/lymphoma-tx-failed-and-negative/"},{"id":"richter-transformation","kind":"term","name":"Richter transformation","route":"/terms/richter-transformation/"},{"id":"step-up-dosing","kind":"term","name":"Step-up dosing (T-cell engagers)","route":"/terms/step-up-dosing/"},{"id":"lymphoma-tx-uk-access","kind":"term","name":"What the NHS in England funds for lymphoma, appraisal by appraisal","route":"/terms/lymphoma-tx-uk-access/"}],"idea":[{"id":"idea-bispecific-vs-car-t-second-line","kind":"idea","name":"Head-to-head bispecific vs CAR-T in second-line LBCL","route":"/ideas/idea-bispecific-vs-car-t-second-line/"}],"roadmap":[{"id":"lymphoma-roadmap","kind":"roadmap","name":"Lymphoma roadmap: from a jaw tumour in Uganda and the first human cancer virus to gene-expression subtypes, PET-adapted chemotherapy, CAR-T cells, bispecific antibodies and the genetics-directed trials now recruiting","route":"/roadmaps/lymphoma-roadmap/"}],"person":[{"id":"michael-dickinson","kind":"person","name":"Michael Dickinson","route":"/people/michael-dickinson/"}],"paper":[{"id":"paper-epcore-nhl-1-epcoritamab-jco-2023","kind":"paper","name":"EPCORE NHL-1: epcoritamab, a subcutaneous CD20 x CD3 bispecific, in relapsed large B-cell lymphoma including after CAR-T","route":"/key-papers/paper-epcore-nhl-1-epcoritamab-jco-2023/"}],"institution":[{"id":"sant-orsola-bologna","kind":"institution","name":"IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico Sant'Orsola","route":"/institutions/sant-orsola-bologna/"}],"biomarker":[{"id":"cd20-expression","kind":"biomarker","name":"CD20 expression (CD20-positive)","route":"/biomarkers/cd20-expression/"}]}}