{"entity":{"id":"mosunetuzumab","kind":"drug","name":"Mosunetuzumab","aka":[],"tldr":"Mosunetuzumab is a fixed-duration CD20 bispecific approved for follicular lymphoma and studied with polatuzumab in large B-cell lymphoma.","summary":"Mosunetuzumab is a full-length humanised IgG1 CD20xCD3 bispecific antibody that brings T cells to CD20-positive B cells, given with step-up dosing for a fixed 8 to 17 cycles depending on response. It was approved in December 2022 for relapsed or refractory follicular lymphoma after at least 2 lines, where it produced ORR 80% and CR 60%. In DLBCL, mosunetuzumab plus polatuzumab vedotin met its PFS endpoint in the phase 3 SUNMO trial against R-GemOx in transplant-ineligible relapsed disease in 2025, positioning the chemotherapy-free, outpatient doublet for patients not fit for CAR-T. A subcutaneous formulation was approved in 2025. Cytokine release syndrome occurred in 44% of the follicular lymphoma cohort but was grade 3 or higher in only 2%; Roche develops it. Its distinguishing point is fixed-duration treatment, so patients stop rather than continuing indefinitely.","status":"approved","asOf":"2026-09-07","wikipedia":"https://en.wikipedia.org/wiki/Mosunetuzumab","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Mosunetuzumab"}],"tags":[],"related":[],"cancers":["dlbcl"],"sections":[],"technologies":["t-cell-engager"],"targets":["cd20","cd3"],"drugs":["polatuzumab-vedotin"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":["sunmo","nct04712097","nct06090539","nct04246086","nct05207670","nct03671018","nct06634589"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Lunsumio","modality":"Bispecific T-cell engager (CD20×CD3)","mechanism":"Full-length humanised IgG1 CD20×CD3 bispecific with step-up dosing; fixed 8-17 cycles.","approvals":[{"region":"US","year":2022,"indication":"R/R follicular lymphoma after ≥2 lines (accelerated)"}],"mechanismSteps":[],"dosing":{"route":"IV or subcutaneous","schedule":"Step-up 1 mg, 2 mg, 60 mg in cycle 1, 60 mg cycle 2, 30 mg thereafter; 8 cycles if CR, up to 17 if PR/SD","monitoring":"CRS cycle 1; tumour flare; infections"},"toxicity":[{"event":"Cytokine release syndrome","anyGradePct":44,"grade3PlusPct":2,"note":"GO29781 FL cohort"},{"event":"Neutropenia","grade3PlusPct":27}],"access":[],"regulatoryEvents":[{"date":"2022-12-22","type":"accelerated-approval","region":"US","note":"Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 3.7 years later, when the FDA's table was read.","indication":"Adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy."},{"date":"2025-12-19","type":"accelerated-approval","region":"US","note":"Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 0.7 years later, when the FDA's table was read.","indication":"Formulation: Treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy."}]},"route":"/drugs/mosunetuzumab/","neighbours":{"cancer":[{"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/"}],"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/"}],"drug":[{"id":"polatuzumab-vedotin","kind":"drug","name":"Polatuzumab vedotin","route":"/drugs/polatuzumab-vedotin/"}],"company":[{"id":"roche-genentech","kind":"company","name":"Roche / Genentech","route":"/companies/roche-genentech/"}],"trial":[{"id":"nct04712097","kind":"trial","name":"A Study Evaluating the Efficacy and Safety of Mosunetuzumab in Combination With Lenalidomide in Comparison to Rituximab in Combination With Lenalidomi","route":"/trials/nct04712097/"},{"id":"nct05207670","kind":"trial","name":"A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab Monotherapy in Participants With Select B-Cell Malignancies","route":"/trials/nct05207670/"},{"id":"nct04246086","kind":"trial","name":"A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab + Lenalidomide (+Len), and the Safety, Tolerability, and Pharmacokineti","route":"/trials/nct04246086/"},{"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":"nct06828991","kind":"trial","name":"A Study to Evaluate the Impact of Mosunetuzumab Consolidation for Older Patients With Diffuse Large B-cell Lymphoma (DLBCL) Who Have Detectable Amounts of ctDNA (Circulating Tumor DNA) at the End of Treatment With Pola-R-mini-CHP","route":"/trials/nct06828991/"},{"id":"nct03671018","kind":"trial","name":"A Study to Evaluate the Safety and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With Polatuzumab Vedotin in B-Cell Non-Hodgkin Lymphoma","route":"/trials/nct03671018/"},{"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":"mosun-lbt-fl","kind":"trial","name":"Mosunetuzumab against rituximab in low tumour burden follicular lymphoma","route":"/trials/mosun-lbt-fl/"},{"id":"mosun-len-mzl","kind":"trial","name":"Mosunetuzumab with lenalidomide in relapsed marginal zone lymphoma","route":"/trials/mosun-len-mzl/"},{"id":"sunmo","kind":"trial","name":"SUNMO","route":"/trials/sunmo/"}],"pairing":[{"id":"bispecific-plus-adc-lymphoma","kind":"pairing","name":"CD20 bispecific + CD79b ADC (mosunetuzumab + polatuzumab)","route":"/pairings/bispecific-plus-adc-lymphoma/"}],"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-tx-pod24","kind":"term","name":"POD24: progression of follicular lymphoma within two years, and why it changes the plan","route":"/terms/lymphoma-tx-pod24/"},{"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/"}],"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/"}],"idea":[{"id":"lymphoma-ev-fixed-duration-chemotherapy-free-first-line","kind":"idea","name":"Fixed-duration, chemotherapy-free first-line treatment for the indolent lymphomas","route":"/ideas/lymphoma-ev-fixed-duration-chemotherapy-free-first-line/"}],"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/"}],"biomarker":[{"id":"cd20-expression","kind":"biomarker","name":"CD20 expression (CD20-positive)","route":"/biomarkers/cd20-expression/"}]}}