COLUMVI
Columvi (glofitamab-gxbm) is a bispecific CD20-directed CD3 T-cell engager. It is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, or large B-cell lymphoma arising from follicular lymphoma. This therapy is used after patients have received two or more lines of systemic therapy. The drug received accelerated approval based on response rate and durability of response, and continued approval may be contingent upon verification of clinical benefit in confirmatory trials.
How COLUMVI Works
Glofitamab-gxbm is a bispecific antibody that binds to CD20 expressed on the surface of B cells and the CD3 receptor expressed on the surface of T cells. This dual binding causes T-cell activation and proliferation as well as the secretion of cytokines. These actions result in the lysis of CD20-expressing B cells. The drug has demonstrated anti-tumor activity in vivo in models of diffuse large B-cell lymphoma.
Details
- Status
- Prescription
- First Approved
- 2023-06-15
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
COLUMVI Approval History
What COLUMVI Treats
2 indicationsCOLUMVI is approved for 2 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Diffuse Large B-Cell Lymphoma
- Follicular Lymphoma
COLUMVI Boxed Warning
CYTOKINE RELEASE SYNDROME Cytokine Release Syndrome (CRS), including serious or fatal reactions, can occur in patients receiving COLUMVI. Premedicate before each dose, and initiate treatment with the COLUMVI step-up dosing schedule to reduce the risk of CRS. Withhold COLUMVI until CRS resolves or permanently discontinue based on severity [see Dosage and Administration (2.1 , 2.2 , 2.3 , and 2.4) and Warnings and Precautions (5.1) ] . WARNING: CYTOKINE RELEASE SYNDROME See full prescribing inform...
WARNING: CYTOKINE RELEASE SYNDROME Cytokine Release Syndrome (CRS), including serious or fatal reactions, can occur in patients receiving COLUMVI. Premedicate before each dose, and initiate treatment with the COLUMVI step-up dosing schedule to reduce the risk of CRS. Withhold COLUMVI until CRS resolves or permanently discontinue based on severity [see Dosage and Administration (2.1 , 2.2 , 2.3 , 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 fatal reactions, can occur in patients receiving COLUMVI. Premedicate before each dose, and initiate treatment with the COLUMVI step-up dosing schedule to reduce the risk of CRS. Withhold COLUMVI until CRS resolves or permanently discontinue based on severity. ( 2.1 , 2.2 , 2.3 , 2.4 , 5.1 )
COLUMVI 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.
COLUMVI 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.
COLUMVI FDA Label Details
ProIndications & Usage
FDA Label (PDF)COLUMVI is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS) or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy. This indication is approved under accelerated approval based on response rate and durability of response [see Clinical Studies ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). COLUMVI is a bispecific CD20-directed CD3 T-cell engager indicated...
WARNING: CYTOKINE RELEASE SYNDROME Cytokine Release Syndrome (CRS), including serious or fatal reactions, can occur in patients receiving COLUMVI. Premedicate before each dose, and initiate treatment with the COLUMVI step-up dosing schedule to reduce the risk of CRS. Withhold COLUMVI until CRS resol...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.