Tafasitamab is a CD19-directed cytolytic monoclonal antibody used in the treatment of B-cell malignancies.

Brand Names
Generic Name
DrugBank Accession Number

Tafasitamab is a humanized, CD19-directed cytolytic monoclonal antibody intended for the treatment of B-cell malignancies.6 It is produced using recombinant DNA technology in Chinese hamster ovary cells, and contains an IgG1/2 hybrid Fc-domain which has been modified with 2 amino acid substitutions to enhance its cytotoxicity relative to non-engineered anti-CD19 antibodies.5,1

The CD19 surface protein is highly expressed on the surface of B-cells, where it appears to play a role in enhancing B-cell receptor signaling.6 Its relative ubiquity across different stages of B-cell development, including pre-B and mature B-lymphocytes,5 as well as its presence in several B-cell malignancies (e.g. chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), diffuse large B-cell lymphoma (DLBCL))6 has made it a desirable target in the treatment these B-cell malignancies. Tafasatimab is designed to bind to and block the activity of the CD19 surface antigen, which ultimately results in the lysis of B-cells (both healthy and malignant).5

Having previously received Breakthrough Therapy, Fast Track, and Orphan designations from the FDA,1 tafasatimab-cxix (Monjuvi®) received an accelerated approval on July 31st, 2020, for the treatment of relapsed or refractory DLBCL in adult patients who cannot receive autologous stem cell transplants.7 It must be used in combination with lenalidomide, as this combination results in greater efficacy as compared to either agent alone.5

Approved, Investigational
Biologic Classification
Protein Based Therapies
Monoclonal antibody (mAb)
Protein Chemical Formula
Not Available
Protein Average Weight
150000.0 Da
Not Available
  • Tafasitamab
  • tafasitamab-cxix
External IDs
  • MOR-00208
  • MOR-208
  • MOR00208
  • WHO 10835
  • XmAb 5574
  • XmAb-5574
  • XmAb5574



Tafasitamab is indicated, in combination with lenalidomide, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified whom are ineligible for autologous stem cell transplant (ASCT).5

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Associated Conditions
Indication TypeIndicationCombined Product DetailsApproval LevelAge GroupPatient CharacteristicsDose Form
Used in combination to treatRefractory diffuse large b-cell lymphoma nosRegimen in combination with: Lenalidomide (DB00480)••••••••••••••••••••••••••• ••• •••••••••• •••• •••• •••••••••••••••••••
Used in combination to treatRelapsed diffuse large b-cell lymphoma nosRegimen in combination with: Lenalidomide (DB00480)••••••••••••••••••••••••••• ••• •••••••••• •••• •••• •••••••••••••••••••
Contraindications & Blackbox Warnings
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Tafasitamab induces a reduction in circulating B-cell counts by binding to a surface antigen, CD19, which is important for their survival.6 Patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) experienced a 97% reduction in peripheral blood B-cell counts following 8 days of treatment, with a 100% reduction reached within 16 weeks of treatment.5

Tafasitamab can cause infusion-related reactions, particularly during the initial cycles of therapy. Symptoms may include chills, flushing, dyspnea, and hypertension. Patients may be administered premedications (such as acetaminophen, antihistamines, or glucocorticoids) 0.5 - 2 hours prior to infusion to minimize infusion-related reactions.5 Tafasitamab may also cause significant myelosuppression, and subsequent infection, due to its mechanism of action - patients should undergo monitoring throughout therapy for signs of myelosuppression and/or infection.5

Mechanism of action

The CD19 surface antigen is a protein expressed on the surface of pre-B and mature B-lymphocytes5 that appears to play a role in enhancing B-cell receptor signaling and is considered integral to their survival.6 These surface proteins are also highly expressed on several B-cell malignancies, such as chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and diffuse large B-cell lymphoma (DLBCL).6

Tafasitamab is a CD19-directed cytolytic monoclonal antibody that, upon binding and blocking the activity of CD19, causes lysis of B-cells. This process is mediated through both direct apoptosis and immune-mediated effector mechanisms, such as antibody-dependent cellular cytotoxicity (ADCC) and antibody-dependent cellular phagocytosis (ADCP).5

UB-lymphocyte antigen CD19

Following intravenous administration of tafasitamab 12 mg/kg on Days 1, 8, 15, and 22 in cycle(s) 1-3 (with an additional dose on Day 4 of cycle 1), mean trough concentrations were 179 (± 53) μg/mL. From cycle 4 onwards, which involve the administration of tafasitamab 12 mg/kg on Days 1 and 15, mean trough concentrations were 153 (± 68) μg/mL.5

The overall maximum tafasitamab serum concentrations reached were 483 (± 109) μg/mL.5

Volume of distribution

The total volume of distribution of tafasitamab following intravenous injection is approximately 9.3 L.5

Protein binding

Not Available


The biotransformation of tafasitamab has not been elucidated. Most monoclonal antibodies undergo intracellular catabolism via lysosomal degradation to smaller amino acids and peptides.3,4

Route of elimination

Monoclonal antibodies are typically eliminated via uptake into cells and subsequent catabolism via lysosomal degradation. Due to their large size, they are only eliminated renally under pathologic conditions.4


The terminal elimination half-life of tafasitamab is approximately 17 days.5


The clearance of tafasitamab is approximately 0.41 L/day.5

Adverse Effects
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Data regarding overdose of tafasitamab are unavailable. Symptoms of overdosage are likely to be consistent with its adverse effect profile, and may therefore involve significant infusion-related reactions and/or myelosuppression.5

Not Available
Pharmacogenomic Effects/ADRs
Not Available


Drug Interactions
This information should not be interpreted without the help of a healthcare provider. If you believe you are experiencing an interaction, contact a healthcare provider immediately. The absence of an interaction does not necessarily mean no interactions exist.
AbciximabThe risk or severity of adverse effects can be increased when Abciximab is combined with Tafasitamab.
AdalimumabThe risk or severity of adverse effects can be increased when Adalimumab is combined with Tafasitamab.
AducanumabThe risk or severity of adverse effects can be increased when Aducanumab is combined with Tafasitamab.
AlemtuzumabThe risk or severity of adverse effects can be increased when Alemtuzumab is combined with Tafasitamab.
AlirocumabThe risk or severity of adverse effects can be increased when Alirocumab is combined with Tafasitamab.
Food Interactions
No interactions found.


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Brand Name Prescription Products
NameDosageStrengthRouteLabellerMarketing StartMarketing EndRegionImage
MinjuviPowder, for solution200 mg / vialIntravenousIncyte Corporation2021-12-06Not applicableCanada flag
MinjuviInjection, powder, for solution200 mgIntravenousIncyte Biosciences Distribution B.V.2021-10-06Not applicableEU flag
MonjuviInjection, powder, lyophilized, for solution200 mg/5mLIntravenousIncyte Corporation2020-08-05Not applicableUS flag
MonjuviInjection, powder, lyophilized, for solution200 mg/5mLIntravenousMorphoSys US Inc.2020-08-05Not applicableUS flag


ATC Codes
L01FX12 — Tafasitamab
Drug Categories
Chemical TaxonomyProvided by Classyfire
Not Available
Organic Compounds
Super Class
Organic Acids
Carboxylic Acids and Derivatives
Sub Class
Amino Acids, Peptides, and Analogues
Direct Parent
Alternative Parents
Not Available
Not Available
Molecular Framework
Not Available
External Descriptors
Not Available
Affected organisms
Not Available

Chemical Identifiers

CAS number


Synthesis Reference

패트릭 가리델, 안드레아스 란게르, 마틴 헤슬링, 다니엘 바인퍼트너, 보도 브록스. Anti-CD19 antibody preparation. South Korean Patent KR20190021373A. Published March 5, 2019.

General References
  1. Kaplon H, Muralidharan M, Schneider Z, Reichert JM: Antibodies to watch in 2020. MAbs. 2020 Jan-Dec;12(1):1703531. doi: 10.1080/19420862.2019.1703531. [Article]
  2. Ryman JT, Meibohm B: Pharmacokinetics of Monoclonal Antibodies. CPT Pharmacometrics Syst Pharmacol. 2017 Sep;6(9):576-588. doi: 10.1002/psp4.12224. Epub 2017 Jul 29. [Article]
  3. Keizer RJ, Huitema AD, Schellens JH, Beijnen JH: Clinical pharmacokinetics of therapeutic monoclonal antibodies. Clin Pharmacokinet. 2010 Aug;49(8):493-507. doi: 10.2165/11531280-000000000-00000. [Article]
  4. Temrikar ZH, Suryawanshi S, Meibohm B: Pharmacokinetics and Clinical Pharmacology of Monoclonal Antibodies in Pediatric Patients. Paediatr Drugs. 2020 Apr;22(2):199-216. doi: 10.1007/s40272-020-00382-7. [Article]
  5. FDA Approved Drug Products: Monjuvi (tafasitamab-cxix) for intravenous injection [Link]
  6. Morphosys Proprietary Portfolio: Tafasitamab (MOR208) [Link]
  7. FDA Drug Approvals: FDA grants accelerated approval to tafasitamab-cxix for diffuse large B-cell lymphoma [Link]

Clinical Trials

Clinical Trials


Not Available
Not Available
Dosage Forms
Injection, powder, for solutionIntravenous200 MG
Powder, for solutionIntravenous200 mg / vial
Injection, powder, lyophilized, for solutionIntravenous200 mg/5mL
Not Available
Not Available


Experimental Properties
Not Available


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Pharmacological action
General Function
Receptor signaling protein activity
Specific Function
Assembles with the antigen receptor of B-lymphocytes in order to decrease the threshold for antigen receptor-dependent stimulation.
Gene Name
Uniprot ID
Uniprot Name
B-lymphocyte antigen CD19
Molecular Weight
61127.985 Da
  1. FDA Approved Drug Products: Monjuvi (tafasitamab-cxix) for intravenous injection [Link]

Drug created at May 20, 2019 14:44 / Updated at April 01, 2022 20:22