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MONJUVI (TAFASITAMAB-CXIX)
MONJUVI (generic name: TAFASITAMAB-CXIX) is a drug developed by MORPHOSYS US INC. It is currently FDA-approved for Diffuse large B-cell lymphoma refractory, Malignant lymphoma, large B-cell, diffuse.
Tafasitamab is an antibody that binds to the B-lymphocyte antigen CD19. It is used as a treatment for various types of recurrent B-cell lymphoma, including diffuse large B-cell lymphoma, follicular lymphoma, and high-grade B-cell lymphoma with MYC and BCL2 or BCL6 rearrangements.
At a glance
| Generic name | TAFASITAMAB-CXIX |
|---|---|
| Sponsor | MORPHOSYS US INC |
| Target | B-lymphocyte antigen CD19 |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Approved indications
- Diffuse large B-cell lymphoma refractory
- Malignant lymphoma, large B-cell, diffuse
Common side effects
- Neutropenia
- Fatigue
- Anemia
- Diarrhea
- Thrombocytopenia
- Cough
- Pyrexia
- Peripheral edema
- Respiratory tract infection
- Decreased appetite
Serious adverse events
- Infections
- Pneumonia
- Febrile neutropenia
- Cerebrovascular accident
- Respiratory failure
- Progressive multifocal leukoencephalopathy
- Sudden death
Key clinical trials
- A Phase 2 Study With a Safety Lead-In of the Anti-CD19 Antibody Tafasitamab With the BTK Inhibitor Zanubrutinib in Newly Diagnosed Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) - T (Phase 2)
- A PHASE 1b/2 STUDY OF PF-07901801, A CD47 BLOCKING AGENT, WITH TAFASITAMAB AND LENALIDOMIDE FOR PARTICIPANTS WITH RELAPSED/REFRACTORY DIFFUSE LARGE B CELL LYMPHOMA NOT ELIGIBLE FOR STEM CELL TRANSPLAN (Phase 1)
- Randomized Phase II Study of the Addition of Targeted Therapeutic Agents to Tafasitamab-Based Therapy in Non-Transplant-Eligible Patients With Relapsed/Refractory Large B-Cell Lymphoma (Phase 2)
- Tafasitamab, Lenalidomide and Venetoclax Combination Therapy for Relapsed or Refractory Mantle Cell Lymphoma (V-MIND): a Phase II Study with Safety Lead-In (Phase 2)
- Phase II Study to Assess the Efficacy of Combined Tafasitamab and Rituximab in Front-Line Treatment of Post-Transplant Lymphoproliferative Disorder (Phase 2)
- A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Trial Comparing the Efficacy and Safety of Tafasitamab Plus Lenalidomide in Addition to R-CHOP Versus R-CHOP in Previously Untreate (Phase 3)
- Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders (Phase 1)
- Smart Stop: A Phase II Trial of Rituximab, Lenalidomide, Acalabrutinib, Tafasitamab Prior to and With Standard Chemotherapy for Patients With Newly Diagnosed DLBCL (Phase 2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- MONJUVI CI brief — competitive landscape report
- MONJUVI updates RSS · CI watch RSS
- MORPHOSYS US INC portfolio CI
Frequently asked questions about MONJUVI
What is MONJUVI?
What is MONJUVI used for?
Who makes MONJUVI?
What is the generic name of MONJUVI?
What development phase is MONJUVI in?
What are the side effects of MONJUVI?
What does MONJUVI target?
Related
- Target: All drugs targeting B-lymphocyte antigen CD19
- Manufacturer: MORPHOSYS US INC — full pipeline
- Therapeutic area: All drugs in Oncology
- Indication: Drugs for Diffuse large B-cell lymphoma refractory
- Indication: Drugs for Malignant lymphoma, large B-cell, diffuse
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing