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Xmab5574 (tafasitamab)
Tafasitamab works by binding to the CD19 antigen on B-lymphocytes, triggering an immune response against cancer cells.
Tafasitamab, also known as Xmab5574, is a monoclonal antibody developed by Morphosys US Inc. It targets the CD19 antigen on B-lymphocytes and is used to treat diffuse large B-cell lymphoma that is refractory to other treatments. Tafasitamab was approved by the FDA in 2020 and is still patented. It has a half-life of 17 days, but its bioavailability is unknown. As a monoclonal antibody, tafasitamab works by binding to CD19 and triggering an immune response against cancer cells.
At a glance
| Generic name | tafasitamab |
|---|---|
| Sponsor | Morphosys Us Inc |
| Target | B-lymphocyte antigen CD19 |
| Modality | Monoclonal antibody |
| Therapeutic area | Oncology |
| Phase | discontinued |
| First approval | 2020 |
| Annual revenue | 100 |
Mechanism of action
Tafasitamab-cxix is an Fc-modified monoclonal antibody that binds to CD19 antigen expressed on the surface of pre-B and mature lymphocytes and on several B-cell malignancies, including diffuse large B-cell lymphoma (DLBCL).Upon binding to CD19, tafasitamab-cxix mediates B-cell lysis through apoptosis and immune effector mechanisms, including antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).In studies conducted in vitro in DLBCL tumor cells, tafasitamab-cxix in combination with lenalidomide resulted in increased ADCC activity compared to tafasitamab-cxix or lenalidomide alone.
Approved indications
- Diffuse large B-cell lymphoma refractory
- Malignant lymphoma, large B-cell, diffuse
Common side effects
- Neutropenia
- Fatigue
- Anemia
- Thrombocytopenia
- Diarrhea
- Cough
- Pyrexia
- Peripheral edema
- Respiratory tract infection
- Decreased appetite
- Infections
- Pneumonia
Key clinical trials
- Study to Assess the Safety and Tolerability of Tafasitamab in Adult Participants With Primary Autoimmune Blood Cell Disorders (PHASE2)
- A Phase II Trial of Mosunetuzumab, Polatuzumab, Tafasitamab, and Lenalidomide in Patients With Relapsed B-cell NHL (PHASE2)
- Chemotherapy (DA-EPOCH+/-R) and Targeted Therapy (Tafasitamab) for the Treatment of Newly-Diagnosed Philadelphia Chromosome Negative B Acute Lymphoblastic Leukemia (PHASE2)
- A Study of Epcoritamab With Lenalidomide and Tafasitamab in People With Diffuse Large B Cell Lymphoma (PHASE2)
- Phase I/II Trial of ONC-PluReceptor NK Cells With Epcoritamab and Tafasitamab for Patients With Recurrent or Refractory B-cell Non-Hodgkin Lymphoma (PHASE1,PHASE2)
- 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) (PHASE1,PHASE2)
- Tafasitamab and Rituximab for Front-Line Treatment of Post-Transplant Lymphoproliferative Disorder (PHASE2)
- Tafasitamab (MOR00208) in Pediatric Patients With Relapsed or Refractory Acute B Lineage Leukemia (PHASE1,PHASE2)
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Xmab5574 CI brief — competitive landscape report
- Xmab5574 updates RSS · CI watch RSS
- Morphosys Us Inc portfolio CI