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Portrazza(necitumumab)
Portrazza (necitumumab) is an antibody pharmaceutical. Necitumumab was first approved as Portrazza on 2015-11-24. It is used to treat non-small-cell lung carcinoma in the USA. It has been approved in Europe to treat non-small-cell lung carcinoma. The pharmaceutical is active against epidermal growth factor receptor.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
respiratory tract diseasesD012140
Trade Name
FDA
EMA
Portrazza
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)
Necitumumab
Tradename
Proper name
Company
Number
Date
Products
PortrazzanecitumumabEli LillyN-125547 RX2015-11-24
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
portrazzaBiologic Licensing Application2017-05-03
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
non-small-cell lung carcinoma—D002289—
Agency Specific
FDA
EMA
Expiration
Code
necitumumab, Portrazza, Eli Lilly and Company
2122-11-24Orphan excl.
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01F: Monoclonal antibodies and antibody drug conjugates
— L01FE: Egfr (epidermal growth factor receptor) inhibitors
— L01FE03: Necitumumab
HCPCS
Code
Description
J9295
Injection, necitumumab, 1 mg
Clinical
Clinical Trials
23 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
Non-small-cell lung carcinomaD002289782——15
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369C8032———5
Squamous cell neoplasmsD01830712———2
Lung neoplasmsD008175C34.9011———1
Colorectal neoplasmsD015179—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Neoplasm metastasisD009362EFO_00097081————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameNECITUMUMAB
INNnecitumumab
Description
Necitumumab (human mab)
Classification
Antibody
Drug classmonoclonal antibodies
Image (chem structure or protein)NECITUMUMAB
Structure (InChI/SMILES or Protein Sequence)
>6B3S:H,C,F,J|Necitumumab Fab Heavy chain QVQLQESGPGLVKPSQTLSLTCTVSGGSISSGDYYWSWIRQPPGKGLEWIGYIYYSGSTDYNPSLKSRVTMSVDTSKNQF SLKVNSVTAADTAVYYCARVSIFGVGTFDYWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGTAALGCLVKDYFPEPVTVS WNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKS >6B3S:L,D,G,K|Necitumumab Fab Light chain EIVMTQSPATLSLSPGERATLSCRASQSVSSYLAWYQQKPGQAPRLLIYDASNRATGIPARFSGSGSGTDFTLTISSLEP EDFAVYYCHQYGSTPLTFGGGTKAEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQ ESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGA
Identifiers
PDB6B3S
CAS-ID906805-06-9
RxCUI—
ChEMBL IDCHEMBL1743047
ChEBI ID—
PubChem CID—
DrugBankDB09559
UNII ID2BT4C47RUI (ChemIDplus, GSRS)
Target
Agency Approved
EGFR
EGFR
Organism
Homo sapiens
Gene name
EGFR
Gene synonyms
ERBB, ERBB1, HER1
NCBI Gene ID
1956
Protein name
epidermal growth factor receptor
Protein synonyms
avian erythroblastic leukemia viral (v-erb-b) oncogene homolog, cell growth inhibiting protein 40, cell proliferation-inducing protein 61, EGFR vIII, epidermal growth factor receptor tyrosine kinase domain, erb-b2 receptor tyrosine kinase 1, Proto-oncogene c-ErbB-1, Receptor tyrosine-protein kinase erbB-1
Uniprot ID
Q9UMG5
Mouse ortholog
Egfr (13649)
epidermal growth factor receptor (Q01279)
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
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Additional graphs summarizing 798 documents
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Safety
Black-box Warning
Black-box warning for: Portrazza
Adverse Events
Top Adverse Reactions
Mock data
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38 adverse events reported
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