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Mosunetuzumab is a fixed-duration CD20 bispecific approved for follicular lymphoma and studied with polatuzumab in large B-cell lymphoma.
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.
1.One arm of Mosunetuzumab binds CD20 on the cancer cell.
Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies. Step-up dosing is often started in hospital (Part A) because of cytokine release syndrome monitoring, then continued in the outpatient setting.
Covered under the medical benefit with prior authorisation confirming diagnosis, biomarker status and line of therapy; site-of-care policies may steer infusions away from hospital outpatient departments.
20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.
Sources: NICE TA892 · SMC advice: mosunetuzumab. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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Adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 3.7 years later, when the FDA's table was read.
Formulation: Treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy.
Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 0.7 years later, when the FDA's table was read.
| Region | Year | Indication |
|---|---|---|
| US | 2022 | R/R follicular lymphoma after ≥2 lines (accelerated) |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Cytokine release syndrome | 44% | 2% |
| Neutropenia | - | 27% |
GO29781 FL cohort. Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
Read for the class this product belongs to (bispecific t-cell engagers) unless the answer names the product. Population figures from the cohorts named, not a prediction for one person. Blank where no source gives a recovery figure.
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Query for this drug: (TITLE:"Mosunetuzumab" OR ABSTRACT:"Mosunetuzumab" OR TITLE:"Lunsumio" OR ABSTRACT:"Lunsumio") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Mosunetuzumab, not a curated reading list.
Shares 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, A Study to Assess BMS-986458 Alone and in Combination With Anti-lymphoma Agents in Relapsed/Refractory Non-Hodgkin Lymphomas, Hepatitis B reactivation before rituximab and other anti-CD20 antibodies, CD20 bispecific antibodies: step-up dosing, fixed duration and what it is like to take one.
Shares A Study to Assess BMS-986458 Alone and in Combination With Anti-lymphoma Agents in Relapsed/Refractory Non-Hodgkin Lymphomas, Hepatitis B reactivation before rituximab and other anti-CD20 antibodies, CD20 bispecific antibodies: step-up dosing, fixed duration and what it is like to take one, CD20 expression (CD20-positive).
Shares CD20 bispecific antibodies: step-up dosing, fixed duration and what it is like to take one, EPCORE NHL-1: epcoritamab, a subcutaneous CD20 x CD3 bispecific, in relapsed large B-cell lymphoma including after CAR-T, POD24: progression of follicular lymphoma within two years, and why it changes the plan, Cytokine release syndrome and ICANS: grading and management.
Shares A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab Monotherapy in Participants With Select B-Cell Malignancies, A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab + Lenalidomide (+Len), and the Safety, Tolerability, and Pharmacokineti, A Study to Evaluate the Safety and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With Polatuzumab Vedotin in B-Cell Non-Hodgkin Lymphoma, CD20 bispecific antibodies: step-up dosing, fixed duration and what it is like to take one.
Shares Hepatitis B reactivation before rituximab and other anti-CD20 antibodies, CD20 expression (CD20-positive), Immunoglobulin replacement after CAR-T, bispecifics and long anti-CD20 treatment, Cytokine release syndrome and ICANS: grading and management.
Shares 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, A Study to Assess BMS-986458 Alone and in Combination With Anti-lymphoma Agents in Relapsed/Refractory Non-Hodgkin Lymphomas, Hepatitis B reactivation before rituximab and other anti-CD20 antibodies, CD20 bispecific antibodies: step-up dosing, fixed duration and what it is like to take one.
Shares SUNMO, Polatuzumab vedotin, CD20, Roche / Genentech.
Shares CD3, CD20, T-cell engagers (bispecific), 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.