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Lunsumio (MOSUNETUZUMAB)
Lunsumio (generic name: MOSUNETUZUMAB) is a Monoclonal antibody drug developed by Roche. It is currently FDA-approved (first approved 2022) for Relapsed or refractory follicular lymphoma.
Lunsumio works by binding to the CD20 antigen on B-lymphocytes, triggering their destruction.
Lunsumio (mosunetuzumab) is a monoclonal antibody developed by Genentech Inc, targeting the B-lymphocyte antigen CD20. It is a small molecule modality, approved by the FDA in 2022 for the treatment of relapsed or refractory follicular lymphoma. Lunsumio works by binding to CD20 on cancer cells, marking them for destruction. As a patented product, Lunsumio is not yet available as a generic. Key safety considerations include potential infusion reactions and cytopenias.
At a glance
| Generic name | MOSUNETUZUMAB |
|---|---|
| Sponsor | Roche |
| Target | B-lymphocyte antigen CD20 |
| Modality | Monoclonal antibody |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2022 |
Mechanism of action
Mosunetuzumab-axgb is T-cell engaging bispecific antibody that binds to the CD3 receptor expressed on the surface of T-cells and CD20 expressed on the surface of lymphoma cells and some healthy B-lineage cells.In vitro, mosunetuzumab-axgb activated T-cells, caused the release of proinflammatory cytokines, and induced lysis of B-cells.
Approved indications
- Relapsed or refractory follicular lymphoma
Boxed warnings
- WARNING: CYTOKINE RELEASE SYNDROME Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving LUNSUMIO. Initiate treatment with the LUNSUMIO step-up dosing schedule to reduce the risk of CRS. Withhold LUNSUMIO until CRS resolves or permanently discontinue based on severity [see Dosage and Administration (2.1 and 2.4) and Warnings and Precautions (5.1) ] . WARNING: CYTOKINE RELEASE SYNDROME See full prescribing information for complete boxed warning. Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving LUNSUMIO. Initiate treatment with the LUNSUMIO step-up dosing schedule to reduce the risk of CRS. Withhold LUNSUMIO until CRS resolves or permanently discontinue based on severity. ( 2.1 , 2.4 , 5.1 )
Common side effects
- Cytokine release syndrome
- Fatigue
- Pyrexia
- Edema
- Chills
- Rash
- Pruritus
- Dry skin
- Skin exfoliation
- Headache
- Peripheral neuropathy
- Dizziness
Key clinical trials
- Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular Lymphoma (PHASE3)
- Comparing the Effectiveness of the Immunotherapy Agents Rituximab or Mosunetuzumab in Patients With Nodular Lymphocyte-Predominant Hodgkin Lymphoma, NORM Trial (PHASE2)
- Testing the Combination of Anti-cancer Drugs Mosunetuzumab, Polatuzumab Vedotin, and Lenalidomide for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma (PHASE1)
- A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab or Glofitamab in Combination With CC-220 and/or CC-99282 in Participants With B-Cell Non-Hodgkin Lymphoma (PHASE1)
- A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab + Lenalidomide (+Len), and the Safety, Tolerability, and Pharmacokinetics of SC Versus IV Mosunetuzumab + Len in Participants With Follicular Lymphoma (PHASE1,PHASE2)
- A Study to Investigate Safety and Effectiveness of BGB-16673 in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies (PHASE1,PHASE2)
- CAR-T Followed by Bispecific Antibodies (PHASE2)
- A Phase II Trial of Mosunetuzumab, Polatuzumab, Tafasitamab, and Lenalidomide in Patients With Relapsed B-cell NHL (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
| Biologic Exclusivity |
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Lunsumio CI brief — competitive landscape report
- Lunsumio updates RSS · CI watch RSS
- Roche portfolio CI
Frequently asked questions about Lunsumio
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Related
- Target: All drugs targeting B-lymphocyte antigen CD20
- Manufacturer: Roche — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Relapsed or refractory follicular lymphoma
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing