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Naxitamab
Danyelza (naxitamab) is an antibody pharmaceutical. Naxitamab was first approved as Danyelza on 2020-11-25. It is used to treat neuroblastoma in the USA.
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FDA Novel Drug Approvals 2020
Drugs Approved for Childhood Cancers
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
Trade Name
FDA
EMA
Danyelza
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)
Naxitamab
Tradename
Proper name
Company
Number
Date
Products
Danyelzanaxitamab-gqgkY-mAbs TherapeuticsN-761171 RX2020-11-25
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
danyelzaBiologic Licensing Application2021-01-19
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
neuroblastomaEFO_0000621D009447
Agency Specific
FDA
EMA
Expiration
Code
naxitamab, Danyelza, Y-mABs Therapeutics, Inc
2027-11-25Orphan excl.
Patent Expiration
No data
ATC Codes
No data
HCPCS
Code
Description
J9348
Injection, naxitamab-gqgk, 1 mg
Clinical
Clinical Trials
12 clinical trials
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Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeuroblastomaD009447EFO_000062157212
NeoplasmsD009369C80111
OsteosarcomaD012516111
Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SarcomaD01250911
MelanomaD00854511
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameNAXITAMAB
INNnaxitamab
Description
Naxitamab, sold under the brand name Danyelza, is an anti-cancer medication. It is a monoclonal antibody used in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) for people one year of age and older with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow demonstrating a partial response, minor response, or stable disease to prior therapy.
Classification
Antibody
Drug classmonoclonal antibodies
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
Identifiers
PDB
CAS-ID1879925-92-4
RxCUI
ChEMBL IDCHEMBL4297984
ChEBI ID
PubChem CID
DrugBankDB15965
UNII ID9K8GNJ2874 (ChemIDplus, GSRS)
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
Danyelza - Y-mAbs Therapeutics
$
£
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 106 documents
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Safety
Black-box Warning
Black-box warning for: Danyelza
Adverse Events
Top Adverse Reactions
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831 adverse events reported
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