{"entity":{"id":"rituximab","kind":"drug","name":"Rituximab","aka":["Rituximab and Hyaluronidase Human","Rituxan Hycela"],"tldr":"Rituximab was the first antibody ever approved for cancer (1997). It made chemoimmunotherapy the CLL standard for a decade, and biosimilars keep it cheap and everywhere.","summary":"Approved in follicular lymphoma (1997), DLBCL (2006, R-CHOP), CLL (2010, with fludarabine-cyclophosphamide: FCR, the first regimen to show OS benefit in CLL). Superseded in CLL by targeted agents (CLL13, CLL14, ELEVATE-TN) but still used with venetoclax in relapse (MURANO: venetoclax-rituximab 24 months) and in resource-limited settings. Biosimilars (Truxima, Ruxience, Riabni) since 2018.","status":"approved","asOf":"2026-09-07","wikipedia":"https://en.wikipedia.org/wiki/Rituximab","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Rituximab"},{"label":"Hiraga et al., Blood 2009: CD20-negative transformation after rituximab-containing chemotherapy (19 rebiopsied patients)","url":"https://doi.org/10.1182/blood-2008-08-175208"}],"tags":[],"related":["cd20-expression"],"cancers":["cll","dlbcl","marginal-zone-lymphoma","nodular-lymphocyte-predominant-hodgkin-lymphoma"],"sections":[],"technologies":["monoclonal-antibody"],"targets":["cd20"],"drugs":[],"companies":["roche-genentech","hetero","biogen","halozyme","mabion"],"institutions":[],"pathways":["complement-in-cancer"],"terms":["adcc","lymphoma-bio-lineage-antigen-cost","lymphoma-bio-antigen-escape"],"trials":["nct06097364","nct04442022","nct04529772","nct06717347","nct04384484","nct04002297","nct04712097","nct06149286","nct06508658","nct06191744","nct06911502","nct06230224","nct04224493","nct04680052","nct06091865","nct06091254","nct04404283","nct05100862","nct06363994","nct05888493","nct05409066","nct05371093","nct05952024","nct06601504","nct04663347","nct06090539","nct04542824","nct07189065","nct05951959","nct05533775","nct05201248","nct02180711","nct04844866","nct06119685","nct05283720","nct03671018","nct04669171","nct06564038","nct07029737","nct03930953","nct06943872","nct05947851","nct05624554","nct06084936","nct04075292","nct06846671","nct05023980","nct02970318","nct06082102","nct04965493","nct05406401","nct04623541","nct06890884","nct05615974","nct04494503","nct04980222","nct07015242","nct06425302","nct07520006","nct06970743","nct02972840"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["Lymphoma biology: nothing is tested before the first dose, because CD20 is on essentially every mature B-cell lymphoma, and that is also why the treatment empties the normal B-cell compartment. The two consequences worth naming are hepatitis B reactivation, which is screened for, and low immunoglobulin with a blunted vaccine response, which can persist for years. At relapse the question changes: of 19 rebiopsied patients in one series, 5 had become CD20-negative, with lower CD20 messenger RNA in the negative cells from the same patient (Hiraga 2009)."],"brand":"Rituxan / MabThera (and biosimilars)","modality":"Monoclonal antibody (anti-CD20, chimeric)","mechanism":"Chimeric type I anti-CD20 IgG1: CDC, ADCC, and modest direct signalling.","approvals":[{"region":"US","year":1997,"indication":"Relapsed follicular lymphoma; first antibody approved for cancer"},{"region":"US","year":2010,"indication":"CLL with fludarabine and cyclophosphamide"}],"mechanismSteps":["Binds CD20 and clusters it into lipid rafts","Complement is fixed (CDC) and NK cells recruited (ADCC)","B cells and CLL cells are lysed; normal B cells recover after 6-12 months"],"dosing":{"route":"IV or subcutaneous (Rituxan Hycela)","schedule":"CLL: 375 mg/m² cycle 1 then 500 mg/m² cycles 2-6 with chemotherapy or venetoclax","monitoring":"Infusion reactions, HBV reactivation (boxed), PML (boxed), late-onset neutropenia","source":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Rituxan"},"toxicity":[{"event":"Infusion-related reactions (first infusion)","anyGradePct":77,"source":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Rituxan","note":"Historic lymphoma data; lower with premedication"},{"event":"Hepatitis B reactivation","note":"Boxed warning; screen all patients"},{"event":"Late-onset neutropenia","anyGradePct":8}],"access":[],"regulatoryEvents":[]},"route":"/drugs/rituximab/","neighbours":{"biomarker":[{"id":"cd20-expression","kind":"biomarker","name":"CD20 expression (CD20-positive)","route":"/biomarkers/cd20-expression/"}],"cancer":[{"id":"burkitt-leukaemia","kind":"cancer","name":"Burkitt leukaemia","route":"/cancers/burkitt-leukaemia/"},{"id":"burkitt-lymphoma","kind":"cancer","name":"Burkitt lymphoma","route":"/cancers/burkitt-lymphoma/"},{"id":"cll","kind":"cancer","name":"Chronic lymphocytic 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(PTLD)","route":"/cancers/post-transplant-lymphoproliferative-disorder/"},{"id":"primary-cns-lymphoma","kind":"cancer","name":"Primary CNS lymphoma","route":"/cancers/primary-cns-lymphoma/"},{"id":"primary-cutaneous-follicle-centre-lymphoma","kind":"cancer","name":"Primary cutaneous follicle centre lymphoma","route":"/cancers/primary-cutaneous-follicle-centre-lymphoma/"},{"id":"primary-cutaneous-marginal-zone-lymphoma","kind":"cancer","name":"Primary cutaneous marginal zone lymphoma","route":"/cancers/primary-cutaneous-marginal-zone-lymphoma/"},{"id":"primary-testicular-lymphoma","kind":"cancer","name":"Primary large B-cell lymphoma of the testis","route":"/cancers/primary-testicular-lymphoma/"},{"id":"primary-mediastinal-b-cell-lymphoma","kind":"cancer","name":"Primary mediastinal (thymic) large B-cell lymphoma","route":"/cancers/primary-mediastinal-b-cell-lymphoma/"},{"id":"cll-relapsed","kind":"cancer","name":"Relapsed or refractory chronic lymphocytic 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lymphoma","route":"/cancers/t-cell-histiocyte-rich-large-b-cell-lymphoma/"},{"id":"waldenstrom","kind":"cancer","name":"Waldenström macroglobulinaemia","route":"/cancers/waldenstrom/"}],"technology":[{"id":"rejuv-tx-b-cell-aplasia-and-immunoglobulin","kind":"technology","name":"B-cell aplasia and low antibodies after CAR-T and bispecifics, and immunoglobulin replacement","route":"/technologies/rejuv-tx-b-cell-aplasia-and-immunoglobulin/"},{"id":"biosimilar-manufacturing","kind":"technology","name":"Biosimilar manufacturing and comparability","route":"/technologies/biosimilar-manufacturing/"},{"id":"downstream-purification-chromatography","kind":"technology","name":"Downstream purification (Protein A capture, viral clearance, polishing)","route":"/technologies/downstream-purification-chromatography/"},{"id":"monoclonal-antibody","kind":"technology","name":"Monoclonal 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