Mosunetuzumab
Mosunetuzumab is a fixed-duration CD20 bispecific approved for follicular lymphoma and studied with polatuzumab in large B-cell lymphoma.
Approved December 2022 for R/R follicular lymphoma after ≥2 lines (ORR 80%, CR 60%). In DLBCL, mosunetuzumab + polatuzumab (SUNMO, phase 3 vs R-GemOx) met its PFS endpoint in 2025 in transplant-ineligible R/R disease; subcutaneous formulation approved 2025. Roche.
- 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
- Medicare
- Part B (clinician-administered)
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.
- Commercial insurance
- covered with prior authorisation
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.
- Assistance programmes
- Genentech Access Solutions
- Genentech Patient Foundation — Free medicine for eligible patients regardless of insurance type.
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
- Leukemia & Lymphoma Society financial support
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.
- Appraised for
- Relapsed or refractory follicular lymphoma after 2 or more systemic treatments
- Cancer Drugs Fund
- Entered the Cancer Drugs Fund under a managed access agreement; check the current CDF list for whether it has since moved to routine commissioning.
- NHS England
- Routinely funded for the appraised indication (or via managed access)
Sources: NICE TA892 · NHS England Cancer Drugs Fund list · SMC advice: mosunetuzumab. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Approvals
| 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.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Landmark trials in OnCo
Latest papers
topQuery 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.