{"entity":{"id":"obinutuzumab","kind":"drug","name":"Obinutuzumab","aka":[],"tldr":"Obinutuzumab is a glycoengineered CD20 antibody that recruits immune cells and kills B cells more directly than rituximab. Paired with venetoclax for a fixed 12 months in chronic lymphocytic leukaemia, it keeps over half of patients treatment-free six years later, and it is also used in follicular lymphoma; first-dose infusion reactions are common and managed by splitting the dose.","summary":"Glycoengineered for enhanced ADCC and direct cell death. CLL11 (with chlorambucil, OS benefit vs rituximab-chlorambucil), CLL14 (venetoclax-obinutuzumab fixed 12 months: 6-year PFS 53% vs 22%), CLL13 (GIV triplet 5-year PFS 81%), ELEVATE-TN (with acalabrutinib, OS benefit). Also follicular lymphoma and (2024-25) lupus nephritis. Infusion reactions in the first dose are common and managed by split dosing.","status":"approved","asOf":"2026-09-07","wikipedia":"https://en.wikipedia.org/wiki/Obinutuzumab","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Obinutuzumab"}],"tags":[],"related":[],"cancers":["cll","dlbcl","cll-treatment-naive","follicular-lymphoma","non-hodgkin-lymphoma"],"sections":[],"technologies":["monoclonal-antibody"],"targets":["cd20"],"drugs":[],"companies":["roche-genentech"],"institutions":[],"pathways":["complement-in-cancer"],"terms":["adcc"],"trials":["cll14","cll13-gaia","elevate-tn","nct05100862","nct04077723","nct06090539","nct05533775","nct04787042","nct03075696","nct03930953","nct05673057","nct06943872","nct06084936","nct06428019","nct06634589","nct03533283","nct06806033","nct05057494","nct04895436","nct07520006","nct06970743"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["Lymphoma biology: a glycoengineered type II anti-CD20 antibody with higher Fc receptor affinity and more direct cell death, designed around the observation that rituximab depends on effector cells that become refractory with repeated dosing. It does not solve antigen loss, which is a different problem."],"brand":"Gazyva","modality":"Monoclonal antibody (anti-CD20, glycoengineered type II)","mechanism":"Type II anti-CD20 with afucosylated Fc: strong ADCC and direct, caspase-independent cell death; less CDC than rituximab.","approvals":[{"region":"US","year":2013,"indication":"Previously untreated CLL with chlorambucil (CLL11)"},{"region":"US","year":2019,"indication":"Previously untreated CLL with venetoclax, fixed duration (CLL14); with acalabrutinib (ELEVATE-TN)"}],"mechanismSteps":["Obinutuzumab binds CD20 in a type II orientation","Direct actin-dependent lysosomal cell death is triggered","Afucosylated Fc recruits NK cells and macrophages (ADCC, ADCP)","Debulking in cycle 1 lowers TLS risk before venetoclax ramp-up"],"dosing":{"route":"IV","schedule":"Cycle 1: 100 mg day 1, 900 mg day 2, 1000 mg days 8 and 15; then 1000 mg day 1 of cycles 2-6 (with venetoclax from cycle 1 day 22 for 12 cycles total)","monitoring":"Infusion reactions (premedicate), HBV reactivation (boxed), PML (boxed), TLS, neutropenia","source":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Gazyva"},"toxicity":[{"event":"Infusion-related reactions","anyGradePct":45,"grade3PlusPct":9,"source":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Gazyva","note":"CLL14 combination arm"},{"event":"Neutropenia","grade3PlusPct":53,"note":"with venetoclax"},{"event":"Infections","grade3PlusPct":18}],"access":[],"regulatoryEvents":[]},"route":"/drugs/obinutuzumab/","neighbours":{"cancer":[{"id":"cll","kind":"cancer","name":"Chronic lymphocytic leukaemia","route":"/cancers/cll/"},{"id":"cll-treatment-naive","kind":"cancer","name":"Chronic lymphocytic leukaemia, first treatment","route":"/cancers/cll-treatment-naive/"},{"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":"non-hodgkin-lymphoma","kind":"cancer","name":"Non-Hodgkin lymphoma (all types)","route":"/cancers/non-hodgkin-lymphoma/"},{"id":"cll-relapsed","kind":"cancer","name":"Relapsed or refractory chronic lymphocytic leukaemia","route":"/cancers/cll-relapsed/"}],"technology":[{"id":"monoclonal-antibody","kind":"technology","name":"Monoclonal antibodies","route":"/technologies/monoclonal-antibody/"}],"target":[{"id":"cd20","kind":"target","name":"CD20","route":"/targets/cd20/"}],"company":[{"id":"roche-genentech","kind":"company","name":"Roche / Genentech","route":"/companies/roche-genentech/"}],"pathway":[{"id":"complement-in-cancer","kind":"pathway","name":"Complement in cancer","route":"/pathways/complement-in-cancer/"},{"id":"nk-cell-recognition","kind":"pathway","name":"NK-cell recognition: missing self & stress ligands","route":"/pathways/nk-cell-recognition/"}],"term":[{"id":"adcc","kind":"term","name":"ADCC (antibody-dependent cellular cytotoxicity)","route":"/terms/adcc/"},{"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":"cll-ipi","kind":"term","name":"CLL-IPI (chronic lymphocytic leukaemia prognostic index)","route":"/terms/cll-ipi/"},{"id":"flipi","kind":"term","name":"FLIPI, FLIPI2 and POD24 (follicular lymphoma risk)","route":"/terms/flipi/"},{"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-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":"lymphoma-tx-uk-access","kind":"term","name":"What the NHS in England funds for lymphoma, appraisal by appraisal","route":"/terms/lymphoma-tx-uk-access/"}],"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":"nct03930953","kind":"trial","name":"A Safety and Preliminary Efficacy Study of CC-99282, Alone and in Combination With Anti-lymphoma Agents in Participants With Relapsed or Refractory No","route":"/trials/nct03930953/"},{"id":"nct05057494","kind":"trial","name":"A Study of Acalabrutinib Plus Venetoclax Versus Venetoclax Plus Obinutuzumab in Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma","route":"/trials/nct05057494/"},{"id":"nct06970743","kind":"trial","name":"A Study of BGB-16673 Compared to Investigator's Choice in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Previously Exposed to Covalent Bruton Tyrosine Kinase (BTK) Inhibitors","route":"/trials/nct06970743/"},{"id":"nct05100862","kind":"trial","name":"A Study of Zanubrutinib Plus Anti-CD20 Versus Lenalidomide Plus Rituximab in Participants With Relapsed/Refractory Follicular or Marginal Zone Lymphom","route":"/trials/nct05100862/"},{"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":"nct06428019","kind":"trial","name":"A Study to Evaluate the Risk of Tumor Lysis Syndrome (TLS) in Adult Participants Receiving Oral Venetoclax in Combination With Intravenously Infused Obinutuzumab or Oral Acalabrutinib for Previously Untreated Chronic Lymphocytic Leukemia (CLL)","route":"/trials/nct06428019/"},{"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":"nct06943872","kind":"trial","name":"A Study to Investigate Progression-Free Survival With Sonrotoclax Plus Obinutuzumab Or Sonrotoclax Plus Rituximab Compared With Venetoclax Plus Rituximab Treatment In Patients With Relapsed and/or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CELESTIAL-RRCLL)","route":"/trials/nct06943872/"},{"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":"amplify","kind":"trial","name":"AMPLIFY","route":"/trials/amplify/"},{"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":"celestial-tncll","kind":"trial","name":"CELESTIAL-TNCLL","route":"/trials/celestial-tncll/"},{"id":"cll13-gaia","kind":"trial","name":"CLL13 / GAIA","route":"/trials/cll13-gaia/"},{"id":"cll14","kind":"trial","name":"CLL14","route":"/trials/cll14/"},{"id":"elevate-tn","kind":"trial","name":"ELEVATE-TN","route":"/trials/elevate-tn/"},{"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":"fortplus","kind":"trial","name":"FORTplus","route":"/trials/fortplus/"},{"id":"gallium","kind":"trial","name":"GALLIUM","route":"/trials/gallium/"},{"id":"nct06252675","kind":"trial","name":"Glofitamab With Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma","route":"/trials/nct06252675/"},{"id":"glow","kind":"trial","name":"GLOW","route":"/trials/glow/"},{"id":"goya","kind":"trial","name":"GOYA","route":"/trials/goya/"},{"id":"nct04787042","kind":"trial","name":"Phase 1a and Phase 2 Study for Safety, Preliminary Efficacy, PK and PD of ST-067","route":"/trials/nct04787042/"},{"id":"rosewood","kind":"trial","name":"ROSEWOOD","route":"/trials/rosewood/"},{"id":"nct05673057","kind":"trial","name":"Study of MP0533 in Patients Acute Myeloid Leukemia or Myelodysplastic Syndrome","route":"/trials/nct05673057/"},{"id":"nct07520006","kind":"trial","name":"Study of NX-5948 in Combination With Other Agents in Adults With B-cell Malignancies","route":"/trials/nct07520006/"},{"id":"nct04895436","kind":"trial","name":"Study to Assess Change in Disease Activity and Adverse Events of Oral Venetoclax With Intravenous (IV) Obinutuzumab in Adult Participants With Recurring Chronic Lymphocytic Leukemia (CLL)","route":"/trials/nct04895436/"}],"pairing":[{"id":"venetoclax-plus-obinutuzumab","kind":"pairing","name":"Venetoclax + obinutuzumab (12 months)","route":"/pairings/venetoclax-plus-obinutuzumab/"}],"paper":[{"id":"paper-amplify-acalabrutinib-venetoclax-nejm-2025","kind":"paper","name":"AMPLIFY: fixed-duration acalabrutinib plus 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the genetics-directed trials now recruiting","route":"/roadmaps/lymphoma-roadmap/"}],"person":[{"id":"michael-hallek","kind":"person","name":"Michael Hallek","route":"/people/michael-hallek/"}],"drug":[{"id":"ofatumumab","kind":"drug","name":"Ofatumumab","route":"/drugs/ofatumumab/"}],"biomarker":[{"id":"cd20-expression","kind":"biomarker","name":"CD20 expression (CD20-positive)","route":"/biomarkers/cd20-expression/"}]}}