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Identification
- Summary
Tafasitamab is a CD19-directed cytolytic monoclonal antibody used in the treatment of B-cell malignancies.
- Brand Names
- Monjuvi
- Generic Name
- Tafasitamab
- DrugBank Accession Number
- DB15044
- Background
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
- Type
- Biotech
- Groups
- Approved, Investigational
- Biologic Classification
- Protein Based Therapies
Monoclonal antibody (mAb) - Protein Chemical Formula
- Not Available
- Protein Average Weight
- 150000.0 Da
- Sequences
- Not Available
- Synonyms
- Tafasitamab
- tafasitamab-cxix
- External IDs
- MOR-00208
- MOR-208
- MOR00208
- WHO 10835
- XmAb 5574
- XmAb-5574
- XmAb5574
Pharmacology
- Indication
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
Reduce drug development failure ratesBuild, train, & validate machine-learning modelswith evidence-based and structured datasets.Build, train, & validate predictive machine-learning models with structured datasets.- Associated Conditions
Indication Type Indication Combined Product Details Approval Level Age Group Patient Characteristics Dose Form Used in combination to treat Refractory diffuse large b-cell lymphoma nos Regimen in combination with: Lenalidomide (DB00480) •••••••••••• ••••• •••••••••• ••• •••••••••• •••• •••• •••••••••• ••••••••• Used in combination to treat Relapsed diffuse large b-cell lymphoma nos Regimen in combination with: Lenalidomide (DB00480) •••••••••••• ••••• •••••••••• ••• •••••••••• •••• •••• •••••••••• ••••••••• - Contraindications & Blackbox Warnings
Prevent Adverse Drug Events TodayTap into our Clinical API for life-saving information on contraindications & blackbox warnings, population restrictions, harmful risks, & more.Avoid life-threatening adverse drug events with our Clinical API- Pharmacodynamics
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
Target Actions Organism UB-lymphocyte antigen CD19 binderantibodyHumans - Absorption
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
- Metabolism
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
- Half-life
The terminal elimination half-life of tafasitamab is approximately 17 days.5
- Clearance
The clearance of tafasitamab is approximately 0.41 L/day.5
- Adverse Effects
Improve decision support & research outcomesWith structured adverse effects data, including: blackbox warnings, adverse reactions, warning & precautions, & incidence rates. View sample adverse effects data in our new Data Library!Improve decision support & research outcomes with our structured adverse effects data.- Toxicity
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
- Pathways
- Not Available
- Pharmacogenomic Effects/ADRs
- Not Available
Interactions
- 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.
Drug Interaction Integrate drug-drug
interactions in your softwareAbciximab The risk or severity of adverse effects can be increased when Abciximab is combined with Tafasitamab. Adalimumab The risk or severity of adverse effects can be increased when Adalimumab is combined with Tafasitamab. Aducanumab The risk or severity of adverse effects can be increased when Aducanumab is combined with Tafasitamab. Alemtuzumab The risk or severity of adverse effects can be increased when Alemtuzumab is combined with Tafasitamab. Alirocumab The risk or severity of adverse effects can be increased when Alirocumab is combined with Tafasitamab. - Food Interactions
- No interactions found.
Products
Drug product information from 10+ global regionsOur datasets provide approved product information including:dosage, form, labeller, route of administration, and marketing period.Access drug product information from over 10 global regions.- Brand Name Prescription Products
Name Dosage Strength Route Labeller Marketing Start Marketing End Region Image Minjuvi Powder, for solution 200 mg / vial Intravenous Incyte Corporation 2021-12-06 Not applicable Canada 
Minjuvi Injection, powder, for solution 200 mg Intravenous Incyte Biosciences Distribution B.V. 2021-10-06 Not applicable EU 
Monjuvi Injection, powder, lyophilized, for solution 200 mg/5mL Intravenous Incyte Corporation 2020-08-05 Not applicable US 
Monjuvi Injection, powder, lyophilized, for solution 200 mg/5mL Intravenous MorphoSys US Inc. 2020-08-05 Not applicable US
Categories
- ATC Codes
- L01FX12 — Tafasitamab
- Drug Categories
- Amino Acids, Peptides, and Proteins
- Antibodies
- Antibodies, Monoclonal
- Antibodies, Monoclonal, Humanized
- Antineoplastic Agents
- Antineoplastic and Immunomodulating Agents
- Blood Proteins
- Cancer immunotherapy
- Globulins
- Immunoglobulins
- Immunoproteins
- Immunotherapy
- Lymphoma, B-Cell
- Monoclonal antibodies and antibody drug conjugates
- Proteins
- Serum Globulins
- Chemical TaxonomyProvided by Classyfire
- Description
- Not Available
- Kingdom
- Organic Compounds
- Super Class
- Organic Acids
- Class
- Carboxylic Acids and Derivatives
- Sub Class
- Amino Acids, Peptides, and Analogues
- Direct Parent
- Peptides
- Alternative Parents
- Not Available
- Substituents
- Not Available
- Molecular Framework
- Not Available
- External Descriptors
- Not Available
- Affected organisms
- Not Available
Chemical Identifiers
- UNII
- QQA9MLH692
- CAS number
- 1422527-84-1
References
- 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
- 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]
- 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]
- 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]
- 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]
- FDA Approved Drug Products: Monjuvi (tafasitamab-cxix) for intravenous injection [Link]
- Morphosys Proprietary Portfolio: Tafasitamab (MOR208) [Link]
- FDA Drug Approvals: FDA grants accelerated approval to tafasitamab-cxix for diffuse large B-cell lymphoma [Link]
- External Links
- 2387334
- Wikipedia
- Tafasitamab
Clinical Trials
- Clinical Trials
Clinical Trial & Rare Diseases Add-on Data Package
Explore 4,000+ rare diseases, orphan drugs & condition pairs, clinical trial why stopped data, & more. Preview package Phase Status Purpose Conditions Count Start Date Why Stopped 100+ additional columns Unlock 175K+ rows when you subscribe.View sample dataNot Available Approved for Marketing Not Available Diffuse Large B-Cell Lymphoma (DLBCL) 1 somestatus stop reason just information to hide Not Available Not Yet Recruiting Not Available Diffuse Large B-Cell Lymphoma (DLBCL) 1 somestatus stop reason just information to hide Not Available Recruiting Not Available Diffuse Large B-Cell Lymphoma (DLBCL) 1 somestatus stop reason just information to hide 3 Active Not Recruiting Treatment Diffuse Large B-Cell Lymphoma (DLBCL) 1 somestatus stop reason just information to hide 3 Active Not Recruiting Treatment Follicular Lymphoma ( FL) / Marginal Zone Lymphoma (MZL) 1 somestatus stop reason just information to hide
Pharmacoeconomics
- Manufacturers
- Not Available
- Packagers
- Not Available
- Dosage Forms
Form Route Strength Injection, powder, for solution Intravenous 200 MG Powder, for solution Intravenous 200 mg / vial Injection, powder, lyophilized, for solution Intravenous 200 mg/5mL - Prices
- Not Available
- Patents
- Not Available
Properties
- State
- Solid
- Experimental Properties
- Not Available
Targets
- Kind
- Protein
- Organism
- Humans
- Pharmacological action
- Unknown
- Actions
- BinderAntibody
- General Function
- Functions as a coreceptor for the B-cell antigen receptor complex (BCR) on B-lymphocytes. Decreases the threshold for activation of downstream signaling pathways and for triggering B-cell responses to antigens (PubMed:1373518, PubMed:16672701, PubMed:2463100). Activates signaling pathways that lead to the activation of phosphatidylinositol 3-kinase and the mobilization of intracellular Ca(2+) stores (PubMed:12387743, PubMed:16672701, PubMed:9317126, PubMed:9382888). Is not required for early steps during B cell differentiation in the blood marrow (PubMed:9317126). Required for normal differentiation of B-1 cells (By similarity). Required for normal B cell differentiation and proliferation in response to antigen challenges (PubMed:1373518, PubMed:2463100). Required for normal levels of serum immunoglobulins, and for production of high-affinity antibodies in response to antigen challenge (PubMed:12387743, PubMed:16672701, PubMed:9317126)
- Specific Function
- Not Available
- Gene Name
- CD19
- Uniprot ID
- P15391
- Uniprot Name
- B-lymphocyte antigen CD19
- Molecular Weight
- 61127.985 Da
References
- 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