OnCo
drugsProductApproved2022🇪🇺🇬🇧🇯🇵🇦🇺

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.

Schematic of the modality · Bispecific T-cell engager (CD20×CD3) · not a molecule; see the T-cell engagers (bispecific) page
How it works, step by step · animated schematic, not to scale
T-cell engagers (bispecific)
Modality
Bispecific T-cell engager (CD20×CD3)
Mechanism
Full-length humanised IgG1 CD20×CD3 bispecific with step-up dosing; fixed 8-17 cycles.
Brand / code
Lunsumio
Dosing & schedule
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

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.

Cancer Drugs FundNICE TA892 · 2023SMC: accepted
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.

Regulatory

1top

Approvals

RegionYearIndication
US2022R/R follicular lymphoma after ≥2 lines (accelerated)

Safety

2top
Toxicity profile
Adverse eventAny gradeGrade 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

top

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Mosunetuzumab
intervention: Mosunetuzumab
Open on ClinicalTrials.gov →

Country and place are remembered in this browser only. A postcode is sent to OpenStreetMap's Nominatim service to find coordinates when you press the button; nothing else leaves your device.

Landmark trials in OnCo

Key papers

1top

Latest papers

top
Literature trend48 papers in the last 12 months+17% vs prior 12How this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

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.

Connected

10top