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Lumoxiti(moxetumomab pasudotox)
Lumoxiti (moxetumomab pasudotox) is an antibody 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
neoplasmsD009369
hemic and lymphatic diseasesD006425
immune system diseasesD007154
Trade Name
FDA
EMA
Lumoxiti
Drug Products
FDA
EMA
Reference product - 351(a)
Reference product - 351(a)
Interchangeable product - 351(k)
Interchangeable product - 351(k)
Biosimilar product - 351(k)
Biosimilar product - 351(k)
Moxetumomab pasudotox
Tradename
Proper name
Company
Number
Date
Products
Lumoxitimoxetumomab pasudotox-tdfkInnate PharmaN-761104 RX2018-09-13
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
iv solution stabilizer lumoxitiBiologic Licensing Application2019-01-25
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
hairy cell leukemia—D007943C91.4
Agency Specific
FDA
EMA
Expiration
Code
moxetumomab pasudotox, Lumoxiti, Innate Pharma, Inc.
2025-09-13Orphan excl.
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01F: Monoclonal antibodies and antibody drug conjugates
— L01FB: Cd22 (clusters of differentiation 22) inhibitors
— L01FB02: Moxetumomab pasudotox
HCPCS
Code
Description
J9313
Injection, moxetumomab pasudotox-tdfk, 0.01 mg
Clinical
Clinical Trials
14 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hairy cell leukemiaD007943C91.43—1——4
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-hodgkin lymphomaD008228C85.931———3
Precursor cell lymphoblastic leukemia-lymphomaD054198C91.011———2
B-cell chronic lymphocytic leukemiaD015451C91.121———2
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LeukemiaD007938C954————4
Prolymphocytic leukemiaD0154631————1
LymphomaD008223C85.91————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameMOXETUMOMAB PASUDOTOX
INNmoxetumomab 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 classmonoclonal antibodies
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID1020748-57-5
RxCUI—
ChEMBL IDCHEMBL1743043
ChEBI ID—
PubChem CID—
DrugBankDB12688
UNII ID2NDX4B6N8F (ChemIDplus, GSRS)
Target
Agency Approved
CD22
CD22
Organism
Homo sapiens
Gene name
CD22
Gene synonyms
SIGLEC2
NCBI Gene ID
933
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
P20273
Mouse ortholog
Cd22 (12483)
B-cell receptor CD22 (Q9WU51)
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 529 documents
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Safety
Black-box Warning
Black-box warning for: Iv solution stabilizer lumoxiti
Adverse Events
Top Adverse Reactions
Mock data
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972 adverse events reported
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