MONJUVI
Monjuvi (tafasitamab-cxix) is a CD19-directed cytolytic antibody used to treat specific types of relapsed or refractory B-cell lymphomas in adults. It is indicated for use in combination with lenalidomide for patients with diffuse large B-cell lymphoma (DLBCL) who are ineligible for autologous stem cell transplant. The therapy is also approved in combination with lenalidomide and rituximab for the treatment of follicular lymphoma.
How MONJUVI Works
Tafasitamab-cxix is an Fc-modified monoclonal antibody designed to bind to the CD19 antigen expressed on the surface of B lymphocytes and certain B-cell malignancies. Upon binding, the drug induces B-cell lysis through direct apoptosis and immune effector mechanisms, including antibody-dependent cellular cytotoxicity and phagocytosis. Research indicates that combining tafasitamab-cxix with lenalidomide increases the activity of these immune-mediated cell-killing processes.
Details
- Status
- Prescription
- First Approved
- 2020-07-31
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
MONJUVI Approval History
What MONJUVI Treats
3 indicationsMONJUVI is approved for 3 conditions since its original approval in 2020. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Diffuse Large B-Cell Lymphoma
- Follicular Lymphoma
- Marginal Zone Lymphoma
MONJUVI Target & Pathway
ProTarget
A protein expressed on B-cells throughout their development. CD19 is a key target for CAR-T cell therapies in B-cell leukemias and lymphomas, where engineered T-cells are directed to kill CD19-expressing cancer cells.
MONJUVI Competitors
Pro3 other drugs also target CD19. Compare mechanisms, indications, and trial activity.
Competitors share the same molecular target (CD19). 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.
MONJUVI FDA Label Details
ProIndications & Usage
FDA Label (PDF)MONJUVI is a CD19-directed cytolytic antibody indicated: in combination with lenalidomide for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant (ASCT). This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). in combination with lenalidomide and ri...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.