MOXETUMOMAB PASUDOTOX
Lumoxiti (moxetumomab pasudotox) is an antibody drug conjugate pharmaceutical. Moxetumomab pasudotox was first approved as Lumoxiti on 2018-09-13. It is used to treat hairy cell leukemia in the USA. It has been approved in Europe to treat hairy cell leukemia. The pharmaceutical is active against B-cell receptor CD22.
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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 |
|---|---|---|
| iv stabilizer lumoxiti | Biologic Licensing Application | 2020-09-03 |
Indications
FDA
EMA
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Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
moxetumomab pasudotox, Lumoxiti, Innate Pharma, Inc. | |||
| 2025-09-13 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J9313 | Injection, moxetumomab pasudotox-tdfk, 0.01 mg |
Clinical
Clinical Trials
17 clinical trials
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Indications Phases 4
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lymphoma | D008223 | — | C85.9 | 6 | 2 | — | — | — | 7 |
| Lymphoid leukemia | D007945 | — | C91 | 3 | 3 | — | — | — | 5 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | — | 2 | 2 | — | — | — | 4 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 4 | 1 | — | — | — | 4 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | 2 | 1 | — | — | — | 2 |
| Residual neoplasm | D018365 | — | — | — | 1 | — | — | — | 1 |
| B-cell lymphoma | D016393 | — | — | 1 | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Prolymphocytic leukemia | D015463 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sepsis | D018805 | HP_0100806 | A41.9 | — | — | — | — | 1 | 1 |
| Agranulocytosis | D000380 | HP_0012234 | D70 | — | — | — | — | 1 | 1 |
| Toxemia | D014115 | — | — | — | — | — | — | 1 | 1 |
| Opportunistic infections | D009894 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | MOXETUMOMAB PASUDOTOX |
| INN | moxetumomab pasudotox |
| Description | Moxetumomab pasudotox, sold under the brand name Lumoxiti, is an anti-CD22 immunotoxin medication for the treatment of adults with relapsed or refractory hairy cell leukemia (HCL) who have received at least two prior systemic therapies, including treatment with a purine nucleoside analog. Moxetumomab pasudotox is a CD22-directed cytotoxin and is the first of this type of treatment for adults with HCL. The drug consists of the binding fragment (Fv) of an anti-CD22 antibody fused to a toxin called PE38. This toxin is a 38 kDa fragment of Pseudomonas exotoxin A.
|
| Classification | Antibody |
| Drug class | monoclonal antibodies |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1743043 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB12688 |
| UNII ID | 2NDX4B6N8F (ChemIDplus, GSRS) |
Target
Agency Approved
CD22
CD22
Organism
Homo sapiens
Gene name
CD22
Gene synonyms
SIGLEC2
NCBI Gene ID
Protein name
B-cell receptor CD22
Protein synonyms
B-lymphocyte cell adhesion molecule, BL-CAM, CD22, CD22 antigen, Sialic acid-binding Ig-like lectin 2, Siglec-2, T-cell surface antigen Leu-14
Uniprot ID
Mouse ortholog
Cd22 (12483)
B-cell receptor CD22 (Q9WU51)
Alternate
No data
Variants
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Financial
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Trends
PubMed Central
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Additional graphs summarizing 752 documents
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Safety
Black-box Warning
Black-box warning for: Iv stabilizer lumoxiti
Adverse Events
Top Adverse Reactions
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67 adverse events reported
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