TAFASITAMAB
Minjuvi, Monjuvi (tafasitamab) is an antibody pharmaceutical. Tafasitamab was first approved as Monjuvi on 2020-07-31. It is used to treat large b-cell lymphoma diffuse in the USA. It has been approved in Europe to treat large b-cell lymphoma diffuse. The pharmaceutical is active against B-lymphocyte antigen CD19.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| hemic and lymphatic diseases | D006425 |
| immune system diseases | D007154 |
Trade Name
FDA
EMA
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Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| monjuvi | Biologic Licensing Application | 2024-05-31 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
tafasitamab, Monjuvi, MorphoSys US Inc. | |||
| 2027-07-31 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J9349 | Injection, tafasitamab-cxix, 2 mg |
Clinical
Clinical Trials
49 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lymphoma | D008223 | — | C85.9 | 12 | 24 | 4 | — | 4 | 33 |
| B-cell lymphoma | D016393 | — | — | 7 | 12 | 3 | — | 4 | 20 |
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | 6 | 12 | 4 | — | 4 | 20 |
| Follicular lymphoma | D008224 | — | C82 | 1 | 3 | 1 | — | — | 4 |
| B-cell lymphoma marginal zone | D018442 | — | C88.4 | — | 2 | 1 | — | — | 3 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Leukemia | D007938 | — | C95 | 4 | 7 | — | — | — | 9 |
| Lymphoid leukemia | D007945 | — | C91 | 4 | 7 | — | — | — | 9 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | 3 | 4 | — | — | — | 6 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 3 | 5 | — | — | — | 5 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | — | 1 | 3 | — | — | — | 3 |
| Mantle-cell lymphoma | D020522 | — | — | 1 | 3 | — | — | — | 3 |
| Hematologic neoplasms | D019337 | — | — | 1 | 2 | — | — | — | 2 |
| Neoplasms | D009369 | — | C80 | 1 | 2 | — | — | — | 2 |
| Hodgkin disease | D006689 | — | C81 | — | 2 | — | — | — | 2 |
| Recurrence | D012008 | — | — | 1 | 2 | — | — | — | 2 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hematologic diseases | D006402 | EFO_0005803 | D75.9 | 1 | — | — | — | — | 1 |
| Graft vs host disease | D006086 | — | D89.81 | 1 | — | — | — | — | 1 |
| Bronchiolitis obliterans syndrome | D000092122 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Urologic neoplasms | D014571 | — | C64-C68 | — | — | — | — | 1 | 1 |
| Colorectal neoplasms | D015179 | — | — | — | — | — | — | 1 | 1 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | — | — | — | 1 | 1 |
| Head and neck neoplasms | D006258 | — | — | — | — | — | — | 1 | 1 |
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | — | — | — | — | 1 | 1 |
| Melanoma | D008545 | — | — | — | — | — | — | 1 | 1 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | TAFASITAMAB |
| INN | tafasitamab |
| Description | Tafasitamab, sold under the brand name Monjuvi, is a medication used in combination with lenalidomide for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).
|
| Classification | Antibody |
| Drug class | monoclonal antibodies |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 1422527-84-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4298047 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB15044 |
| UNII ID | QQA9MLH692 (ChemIDplus, GSRS) |
Target
Agency Approved
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Minjuvi – Incyte
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Estimated US medical usage
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 573 documents
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Safety
Black-box Warning
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Adverse Events
Top Adverse Reactions
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1,506 adverse events reported
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