LUNSUMIO
LUNSUMIO (mosunetuzumab-axgb) is a bispecific CD20-directed CD3 T-cell engager indicated for the treatment of adult patients with follicular lymphoma. It is specifically used for cases where the disease is relapsed or refractory following two or more lines of systemic therapy. The drug received accelerated approval based on response rate, and its continued indication may depend on the verification of clinical benefit in confirmatory trials.
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.
Details
- Status
- Prescription
- First Approved
- 2022-12-22
- 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 Competitors
Pro10 other drugs also target CD20. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (CD20). Earlier expiry dates signal biosimilar/generic opportunities.
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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
ProIndications & Usage
FDA Label (PDF)LUNSUMIO is a bispecific CD20-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). 1.1 Follicular Lymphoma LUNSUMIO is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy. This indic...
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.