LUNSUMIO (mosunetuzumab-axgb)
LUNSUMIO is indicated for the treatment of Follicular Lymphoma.
How LUNSUMIO Works
Mosunetuzumab-axgb is a bispecific antibody that binds to the CD3 receptor on T-cells and the CD20 antigen on lymphoma cells and certain healthy B-cells. By engaging both targets simultaneously, the drug activates the T-cells and triggers the release of proinflammatory cytokines. This immune activation leads to the direct lysis of the targeted B-cells.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2022-12-22
- Patent Cliff
- 2029
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
LUNSUMIO Approval History
What LUNSUMIO Treats
1 indicationsLUNSUMIO is approved for 1 conditions since its original approval in 2022. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Follicular Lymphoma
LUNSUMIO Boxed 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. ...
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 )
LUNSUMIO Target & Pathway
ProTarget
A protein found on the surface of B-cells but not stem cells or plasma cells. Anti-CD20 antibodies deplete B-cells, making them effective in B-cell cancers and autoimmune diseases where B-cells drive pathology.
LUNSUMIO Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in LUNSUMIO's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications LUNSUMIO treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to LUNSUMIO
3 of 9FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
42 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05886036 | NCI-2023-04108 NCI-2023-04108, 10590 | Ph 2 | recruiting | Comparing the Effectiveness of the Immunotherapy Agents Rituximab or Mosunetuzumab in Patients With Nodular Lymphocyte-Predominant Hodgkin Lymphoma, NORM Trial |
| NCT05169658 results posted | RG1121407 NCI-2021-12489, 10823 | Ph 2 | completed | Mosunetuzumab With or Without Polatuzumab Vedotin and Obinutuzumab for the Treatment of Untreated Indolent B-Cell Non-Hodgkin Lymphoma |
| NCT06015880 | NCI-2023-06477 NCI-2023-06477, PHI-141 | Ph 1 | recruiting | Testing the Combination of Anti-cancer Drugs Mosunetuzumab, Polatuzumab Vedotin, and Lenalidomide for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma |
| NCT06337318 | NCI-2024-02361 NCI-2024-02361, S2308 | Ph 3 | recruiting | Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular Lymphoma |
| NCT05672251 | 22414 NCI-2022-10312, 22414 | Ph 2 | recruiting | Loncastuximab Tesirine and Mosunetuzumab for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma |
| NCT06634589 | BGB-16673-104 2024-516234-35-00, CTR20244676 | Ph 1, Ph 2 | recruiting | A Study to Investigate Safety and Effectiveness of BGB-16673 in Combination With Other Agents in Participants With Relapsed or Refractory B-Cell Malignancies |
| NCT05171647 SUNMO results posted | GO43643 | Ph 3 | active not recruiting | A Study Evaluating Efficacy and Safety of Mosunetuzumab in Combination With Polatuzumab Vedotin Compared to Rituximab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin's Lymphoma |
| NCT04712097 Celestimo | GO42909 2020-005239-53 | Ph 3 | active not recruiting | A Study Evaluating the Efficacy and Safety of Mosunetuzumab in Combination With Lenalidomide in Comparison to Rituximab in Combination With Lenalidomide With a US Extension of Mosunetuzumab in Combination With Lenalidomide in Participants With Follicular Lymphoma |
| NCT07566364 | 2026-0168 NCI-2026-03445 | Ph 2 | not yet recruiting | Phase 2 Study Of Mosunetuzumab In Patients With Chronic Lymphocytic Leukemia With Positive MRD |
| NCT05091424 | BO43243 | Ph 1 | recruiting | A Study Evaluating the Safety, Efficacy, and Pharmacokinetics of Mosunetuzumab and a Combined Regimen of Mosunetuzumab and Venetoclax in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia |
| NCT06594939 | PRO00056497 | Ph 2 | not yet recruiting | Mosunetuzumab and Polatuzumab Vedotin With Split-Dose CHP Chemotherapy for Elderly Patients With Diffuse Large B-Cell Lymphoma |
| NCT07555470 CUREFL03 | IIT2026013 | Ph 2 | not yet recruiting | Mosunetuzumab and Zeprumetostat in Treating Patients With Follicular Lymphoma |
| NCT06249191 | STUDY00023707 NCI-2024-00070, STUDY00023707 | Ph 1, Ph 2 | recruiting | Mosunetuzumab With Chemotherapy for the Treatment of Patients With Untreated C-Myc Rearrangement Positive High Grade B Cell Lymphoma or Diffuse Large B Cell Lymphoma |
| NCT05412290 | 202207137 | Ph 1 | recruiting | Mosunetuzumab Consolidation Therapy After autoSCT in r/r Aggressive B Cell Lymphoma |
| NCT07548450 MPOWER | HCI198712 | Ph 2 | not yet recruiting | Mosunetuzumab in Combination With Pirtobrutinib in Patients With Relapsed or Refractory Waldenstrom Macroglobulinemia (MPOWER) |
| NCT06948786 | RG1125134 NCI-2025-02708, 20877 | Ph 2 | recruiting | Pirtobrutinib and Mosunetuzumab for the Treatment of Relapsed/Refractory Grades 1-3A Follicular Lymphoma, PROMOTE-FL Trial |
| NCT06090539 | CA123-1000 | Ph 1, Ph 2 | recruiting | A Study to Assess BMS-986458 Alone and in Combination With Anti-lymphoma Agents in Relapsed/Refractory Non-Hodgkin Lymphomas |
| NCT05994235 | 23-06026184 22-10025285 | Ph 2 | active not recruiting | Tazemetostat and Mosunetuzumab in Untreated Follicular Lymphoma |
| NCT04889716 | UPCC 48420 | Ph 2 | recruiting | CAR-T Followed by Bispecific Antibodies |
| NCT05615636 | 2022-0459 NCI-2022-09576 | Ph 2 | recruiting | A Phase II Trial of Mosunetuzumab, Polatuzumab, Tafasitamab, and Lenalidomide in Patients With Relapsed B-cell NHL |
| NCT04970901 | ADCT-402-105 2021-001071-16 | Ph 1 | recruiting | A Study to Evaluate the Safety and Anti-cancer Activity of Loncastuximab Tesirine in Combination With Other Anti-cancer Agents in Participants With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (LOTIS-7) |
| NCT06442475 | RG1124175 NCI-2024-02289, 20417 | Ph 2 | recruiting | Low Dose Mosunetuzumab for the Treatment of Patients With Indolent B-Cell Lymphoma |
| NCT05633615 | S2114 NCI-2022-07930, S2114 | Ph 2 | recruiting | Testing Drug Treatments After CAR T-cell Therapy in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma |
| NCT06563505 | 2024-0243 NCI-2024-06965 | Ph 2 | recruiting | A Phase 2 Trial of Mosunetuzumab and Zanubrutinib for Patients With Relapsed/Refractory Marginal Zone Lymphoma |
| NCT05464329 | 202209113 | Ph 1 | active not recruiting | Mosunetuzumab in Combination With Platinum-Based Salvage Chemotherapy in Patients With Relapsed/Refractory Aggressive B Cell Lymphoma |
| NCT05389293 | 22-100 | Ph 2 | recruiting | A Study of Mosunetuzumab Alone or With Zanubrutinib in People With Follicular Lymphoma |
| NCT05260957 | 20210828 | Ph 2 | recruiting | CAR-T Cell Therapy, Mosunetuzumab and Polatuzumab for Treatment of Refractory/Relapsed Aggressive Non-Hodgkin's Lymphoma (NHL). |
| NCT04792502 | BrUOG 401 | Ph 2 | recruiting | Mosunetuzumab With Lenalidomide Augmentation as First-line Therapy for Follicular and Marginal Zone Lymphoma |
| NCT05410418 | 202207147 | Ph 2 | active not recruiting | Mosunetuzumab and Polatuzumab Vedotin for Untreated Follicular Lymphoma |
| NCT07052695 | 25-277 | Ph 1, Ph 2 | recruiting | Mosunetuzumab for CLL MRD Clearance |
| NCT06569680 | 20240178 | Ph 2 | recruiting | Mosunetuzumab in Patients With Newly Diagnosed Extranodal Marginal Zone Lymphoma |
| NCT06828991 GOLD | UMLYM24067 | Ph 2 | recruiting | 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 |
| NCT06453044 | 23003 NCI-2024-04429, 23003 | Ph 2 | recruiting | Mosunetuzumab and Polatuzumab Vedotin for the Treatment of Patients With Relapsed or Refractory Grade 1-3a Follicular Lymphoma |
| NCT07031700 | FL-RR-MOS01 | Ph 2 | not yet recruiting | A Multicenter, Single-Arm, Open-Label, Phase II Trial of Mosunetuzumab in Combination With Tislelizumab for r/r FL |
| NCT05155345 | GA43191 | Ph 1 | completed | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered Mosunetuzumab to Participants With Systemic Lupus Erythematosus |
| NCT03677141 results posted | GO40515 2018-001039-29 | Ph 1, Ph 2 | completed | A Phase Ib/II Study Investigating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Mosunetuzumab (BTCT4465A) in Combination With CHOP or CHP-Polatuzumab Vedotin in Participants With B-Cell Non-Hodgkin Lymphoma |
| NCT06284122 MorningLyte | MorningLyte | Ph 3 | recruiting | Study of Mosunetuzumab Plus Lenalidomide Compared to Anti-CD20 Anti-body + Chemotherapy in Follicular Lymphoma FLIPI2-5 |
| NCT04313608 results posted | GO41943 | Ph 1 | completed | A Study Evaluating the Safety and Efficacy of Glofitamab or Mosunetuzumab in Combination With Gemcitabine Plus Oxaliplatin in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and High-Grade Large B-Cell Lymphoma |
| NCT05849857 MERLIN | EU CT NO: 2022-500100-21-01 NLG-FL6, ML43841 | Ph 2 | recruiting | Mosunetuzumab for Early Relapse of Follicular Lymphoma in the Nordic Countries |
| NCT05961696 | 2022-0530 NCI-2023-05744 | Ph 1 | withdrawn | A Phase I Study of Mosunetuzumab for Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia |
| NCT05205252 ARIA | EZH-1501 | Ph 1, Ph 2 | withdrawn | A Study of Tazemetostat in Combination With Various Treatments in Participants With Blood Cancer. |
| NCT07598396 SOLUNA | GA45799 2024-519930-22-00 | Ph 2 | recruiting | A Study to Evaluate Mosunetuzumab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
LUNSUMIO FDA Label Details
Indications & Usage
FDA Label (PDF)LUNSUMIO is indicated for the treatment of Follicular Lymphoma.
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 d...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment