MONJUVI (tafasitamab-cxix)
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.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2020-07-31
- Patent Cliff
- 2027
- 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 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 MONJUVI's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications MONJUVI treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to MONJUVI
3 of 13FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
44 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07582159 | 25409 NCI-2026-03205, 25409 | Ph 2 | not yet recruiting | Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma |
| NCT05453500 | RG1122464 NCI-2022-05225, 11008 | Ph 2 | active not recruiting | Chemotherapy (DA-EPOCH+/-R) and Targeted Therapy (Tafasitamab) for the Treatment of Newly-Diagnosed Philadelphia Chromosome Negative B Acute Lymphoblastic Leukemia |
| NCT05718869 | 22183 NCI-2022-10205, 22183 | Ph 2 | active not recruiting | Tafasitamab and Zanubrutinib for the Treatment of Patients With Newly Diagnosed Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma, TaZA CLL Study |
| NCT05429268 firmMIND | INCMOR 0208-305 2023-505579-53-00 | Ph 3 | active not recruiting | Study to Evaluate the Safety and Efficacy of Tafasitamab Plus Lenalidomide in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma (firmMIND) |
| NCT04978584 | 2021-0046 NCI-2021-04298, 2021-0046 | Ph 2 | active not recruiting | Rituximab, Lenalidomide, Acalabrutinib, Tafasitamab Alone and With Combination Chemotherapy for the Treatment of Newly Diagnosed Non-germinal Center Diffuse Large B-Cell Lymphoma, Smart Stop Study |
| NCT06434363 | 2024-0208 NCI-2024-04434 | Ph 1, Ph 2 | recruiting | Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders |
| NCT05786040 | OSU-22114 NCI-2023-02048 | Ph 2 | recruiting | Tafasitamab and Rituximab for Front-Line Treatment of Post-Transplant Lymphoproliferative Disorder |
| NCT07030699 ECLAT | 25-070 | Ph 2 | withdrawn | A Study of Epcoritamab With Lenalidomide and Tafasitamab in People With Diffuse Large B Cell Lymphoma |
| NCT04646395 | IELSG49 2019-004396-38 | Ph 2 | active not recruiting | Study of Acalabrutinib and Tafasitamab in MZL Patients |
| NCT06760156 | MCC-21955 | Ph 2 | recruiting | Tafasitamab and Lenalidomide as First Salvage Therapy for Residual Large B Cell Lym |
| NCT04824092 frontMIND | MOR208C310 2022-500237-92-00, 2020-002990-84 | Ph 3 | active not recruiting | Tafasitamab + Lenalidomide + R-CHOP Versus R-CHOP in Newly Diagnosed High-intermediate and High Risk DLBCL Patients |
| NCT07502872 TPG | BrUOG-450 ML46671, I-000585-25-02 | Ph 2 | not yet recruiting | TPG: Tafasitamab, Polatuzumab Vedotin, and Glofitamab as First-line Therapy for Diffuse Large B-cell Lymphoma and High-grade B-cell Lymphoma |
| 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 |
| NCT03930953 | CC-99282-NHL-001 2018-003235-29 | Ph 1, Ph 2 | active not recruiting | A Safety and Preliminary Efficacy Study of CC-99282, Alone and in Combination With Anti-lymphoma Agents in Participants With Relapsed or Refractory Non-Hodgkin Lymphomas (R/R NHL) |
| NCT05366218 Anti-CD19-ALL | 2022-000557-88 2024-511336-28-00 | Ph 1, Ph 2 | recruiting | Tafasitamab (MOR00208) in Pediatric Patients With Relapsed or Refractory Acute B Lineage Leukemia |
| NCT04809467 topMIND results posted | INCMOR 0208-101 2020-005591-35 | Ph 1, Ph 2 | terminated | A Study Evaluating Safety, PK, and Efficacy of Tafasitamab and Parsaclisib in Participants With Relapsed/Refractory Non Hodgkin Lymphoma (R/R NHL) or Chronic Lymphocytic Leukemia (CLL) |
| NCT05222555 MINDway results posted | MOR208C115 2023-507993-42-00, 2021-003855-40 | Ph 1, Ph 2 | active not recruiting | Safety and Pharmacokinetics Study of a Modified Tafasitamab IV Dosing Regimen Combined With Lenalidomide in R-R DLBCL Patients |
| NCT04680052 InMIND results posted | INCMOR 0208-301 2023-504684-16-00, 2020-004407-13 | Ph 3 | active not recruiting | A Phase 3 Study to Assess Efficacy and Safety of Tafasitamab Plus Lenalidomide and Rituximab Compared to Placebo Plus Lenalidomide and Rituximab in Patients With Relapsed/Refractory (R/R) Follicular Lymphoma or Marginal Zone Lymphoma. |
| NCT05455697 | RG1122398 NCI-2022-04527, RG1122398 | Ph 1, Ph 2 | recruiting | Tafasitamab, Retifanlimab, and Rituximab in Combination With Standard Therapy for the Treatment of Diffuse Large B-cell Lymphoma |
| NCT04661007 J-MIND | INCMOR 0208-102 | Ph 1, Ph 2 | active not recruiting | To Assess the Safety and Tolerability of Tafasitamab Alone or in Combination With Other Drugs in Japanese Participants With Non-Hodgkins Lymphoma (NHL) |
| NCT06465433 | MOR208C216 2022-500765-27-00 | Ph 2 | recruiting | Extension Study to Provide Continued Treatment for Patients With Hematologic Malignancies Previously Enrolled in Studies With Tafasitamab |
| NCT05821088 | OSU-22140 NCI-2023-02612 | Ph 2 | recruiting | Tafasitamab and Lenalidomide Followed by Tafasitamab and ICE as Salvage Therapy for Transplant Eligible Patients With Relapsed/ Refractory Large B-Cell Lymphoma |
| NCT05993611 | 22375 NCI-2023-04067, 22375 | Ph 1 | suspended | Allogeneic CD6 Chimeric Antigen Receptor T Regulatory Cells (CD6-CAR Tregs) for the Treatment of Patients With Chronic Graft Versus Host Disease After Allogeneic Hematopoietic Cell Transplantation |
| NCT05943496 | STUDY00024507 NCI-2023-04657, STUDY00024507 | Ph 1 | recruiting | Tafasitamab, Acalabrutinib, and Obinutuzumab for the Treatment of Previously Untreated Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma |
| NCT07225439 | CASE1425 | Ph 1 | not yet recruiting | Rituximab (Rtx) + Tafasitamab in Combination With Allogeneic NK Cells for Treatment of Relapsed/Refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL) |
| NCT05890352 | S2207 NCI-2023-02518, S2207 | Ph 2 | recruiting | Study Adding Drugs to Usual Treatment for Large B-Cell Lymphoma That Returned or Did Not Respond to Treatment |
| NCT06029309 ZANU-TAFA | 20221346 | Ph 1, Ph 2 | recruiting | Zanubrutinib and Tafasitamab in Mantle Cell Lymphoma |
| NCT04607772 | XPORT-DLBCL-025 | Ph 1, Ph 2 | withdrawn | Study of Selinexor in Combination With Backbone Treatments or Novel Therapies In Participants With Relapsed or Refractory (RR) Diffuse Large B-Cell Lymphoma (DLBCL) |
| NCT05626322 results posted | C4971003 2022-502427-21-00 | Ph 1, Ph 2 | terminated | Effects of Maplirpacept (PF-07901801),Tafasitamab, and Lenalidomide in People With Relapsed or Refractory Diffuse Large B-cell Lymphoma |
| NCT05583071 MTR² | Uni-Köln-4968 | Ph 2 | recruiting | Methotrexate, Tafasitamab, Lenalidomide and Rituximab in Patients With PCNSL |
| NCT06792825 | 2023LS183 | Ph 2 | recruiting | HM2023-43:Ph 2 Trial of Tafasitamab With Lenalidomide+Rituximab in Treatment-naive FL and MZL |
| NCT02763319 B-MIND results posted | MOR208C204 2014-004689-11 | Ph 2, Ph 3 | completed | A Trial to Evaluate the Efficacy and Safety of Tafasitamab With Bendamustine (BEN) Versus Rituximab (RTX) With BEN in Adult Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL) |
| NCT05788289 results posted | 22-380 | Ph 2 | terminated | A Study of Tafasitamab and Lenalidomide in People With Mantle Cell Lymphoma |
| NCT05351593 | 212531 NCI-2022-03704 | Ph 1, Ph 2 | recruiting | Tafasitamab Plus Lenalidomide in Relapsed CNS Lymphoma |
| NCT05910801 V-MIND | ACCRU-LY-2101 NCI-2023-03968, ACCRU-LY-2101 | Ph 2 | recruiting | Tafasitamab, Lenalidomide and Venetoclax for the Treatment of Relapsed or Refractory Mantle Cell Lymphoma |
| NCT04134936 results posted | MOR208C107 | Ph 1 | completed | Phase Ib Study to Assess Safety and Preliminary Efficacy of Tafasitamab or Tafasitamab Plus Lenalidomide in Addition to R-CHOP in Patients With Newly Diagnosed DLBCL |
| NCT04974216 | VERLen | Ph 2 | active not recruiting | Study of Tafasitamab and Lenalinomide Associated to Rituximab in Frontline Diffuse Large B-Cell Lymphoma Patients of 80 y/o or Older |
| NCT06521255 | ICP-CL-00903 | Ph 3 | recruiting | Evaluate the Safety and Efficacy of Tafasitamab and Lenalidomide in Combination With Gemcitabine and Oxaliplatin Versus Rituximab in Combination With Gemcitabine and Oxaliplatin in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma |
| NCT05328102 results posted | XmAb13676-03 | Ph 2 | terminated | Phase 2 Study of Plamotamab Combined With Tafasitamab Plus Lenalidomide Versus Tafasitamab Plus Lenalidomide in Relapsed or Refractory (R/R) Diffuse Large-cell B-cell Lymphoma (DLBCL) |
| NCT02399085 L-MIND results posted | MOR208C203 2014-004688-19 | Ph 2 | completed | Open Label Study to Evaluate the Safety and Efficacy of Lenalidomide With MOR00208 in Patients With R-R DLBCL |
| NCT05205252 ARIA | EZH-1501 | Ph 1, Ph 2 | withdrawn | A Study of Tazemetostat in Combination With Various Treatments in Participants With Blood Cancer. |
| NCT02639910 COSMOS results posted | MOR208C205 | Ph 2 | completed | Study to Evaluate Safety and Preliminary Efficacy of Tafasitamab With Idelalisib or Venetoclax in R/R CLL/SLL Patients Pretreated With BTKi |
| NCT04882163 | CC-220-DLBCL-002 2020-005333-32 | Ph 1, Ph 2 | withdrawn | Study to Evaluate Tolerability of Iberdomide (CC-220) in Combination With Polatuzumab Vedotin Plus Rituximab or Tafasitamab or Rituximab Plus Chemotherapy in B-cell Lymphoma |
| NCT07585747 CUREMZL002 | IIT2026026 | Ph 2 | not yet recruiting | A Exploratory Study on Untreated Follicular Lymphoma With Orelabrutinib, Tafasitamab, and Lenalidomide |
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
Indications & Usage
FDA Label (PDF)MONJUVI is indicated for the treatment of Diffuse Large B-Cell Lymphoma; Follicular Lymphoma; Marginal Zone Lymphoma.
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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