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Unituxin(dinutuximab)
Unituxin (dinutuximab) is an antibody pharmaceutical. Dinutuximab was first approved as Unituxin on 2015-03-10. It is used to treat neuroblastoma in the USA. It has been approved in Europe to treat neuroblastoma.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
Trade Name
FDA
EMA
Unituxin
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)
Dinutuximab
Tradename
Proper name
Company
Number
Date
Products
UnituxindinutuximabUnited Therapeutics CorporationN-125516 RX2015-03-10
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
unituxinBiologic Licensing Application2020-10-05
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
neuroblastomaEFO_0000621D009447—
Agency Specific
FDA
EMA
Expiration
Code
dinutuximab, Unituxin, United Therapeutics Corporation
2122-03-10Orphan excl.
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01F: Monoclonal antibodies and antibody drug conjugates
— L01FX: Other monoclonal antibodies and antibody drug conjugates in atc
— L01FX06: Dinutuximab beta
HCPCS
No data
Clinical
Clinical Trials
36 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeuroblastomaD009447EFO_0000621131261130
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
GanglioneuroblastomaD018305—31——4
RetinoblastomaD0121751—1——2
Small cell lung carcinomaD055752—11——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
OsteosarcomaD01251612———3
NeoplasmsD009369C8012———2
Residual neoplasmD018365—1———1
LeiomyosarcomaD007890—1———1
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameDINUTUXIMAB
INNdinutuximab
Description
Dinutuximab (Ch14.18, tradename Unituxin) and Dinutuximab beta (tradename Qarziba) are monoclonal antibodies used as a second-line treatment for children with high-risk neuroblastoma. Each antibody is made of both mouse and human components and targets glycolipid GD2, expressed on neuroblastoma cells and on normal cells of neuroectodermal origin, including the central nervous system and peripheral nerves. They differ in that dinutuximab is manufactured using mouse cells, and dinutuximab beta is manufactured using hamster cells. The dosing regime differs, and dinutuximab is given in combination with granulocyte-macrophage colony stimulating factor (GM-CSF), interleukin-2 (IL-2) and 13-cis-retinoic acid (RA), while dinutuximab beta can be given alone.
Classification
Antibody
Drug classmonoclonal antibodies
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID1363687-32-4
RxCUI1606274
ChEMBL IDCHEMBL3137342
ChEBI ID—
PubChem CID—
DrugBankDB09077
UNII ID7SQY4ZUD30 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Unituxin - United Therapeutics
$
€
£
₣
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 914 documents
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Safety
Black-box Warning
Black-box warning for: Unituxin
Adverse Events
Top Adverse Reactions
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104,259 adverse events reported
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