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Drug ReportsNivolumab
Opdivo(nivolumab)
Opdivo, Opdualag (nivolumab) is an antibody pharmaceutical. Nivolumab was first approved as Opdivo on 2014-12-22. It is used to treat kidney neoplasms, lymphoma, melanoma, non-small-cell lung carcinoma, and squamous cell carcinoma amongst others in the USA. It has been approved in Europe to treat colorectal neoplasms, hodgkin disease, melanoma, mesothelioma, and non-small-cell lung carcinoma amongst others. The pharmaceutical is active against programmed cell death protein 1.
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Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
digestive system diseasesD004066
respiratory tract diseasesD012140
urogenital diseasesD000091642
hemic and lymphatic diseasesD006425
immune system diseasesD007154
Trade Name
FDA
EMA
Opdivo
Combinations
Opdivo qvantig, Opdualag
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)
Nivolumab
Tradename
Proper name
Company
Number
Date
Products
OpdivonivolumabBristol Myers SquibbN-125554 RX2014-12-22
4 products
Nivolumab
+
Relatlimab
Tradename
Proper name
Company
Number
Date
Products
Opdualagnivolumab and relatlimab-rmbwBristol Myers SquibbN-761234 RX2022-03-18
1 products
Hyaluronidase
+
Nivolumab
Tradename
Proper name
Company
Number
Date
Products
Opdivo Qvantignivolumab and hyaluronidase-nvhyBristol Myers SquibbN-761381 RX2024-12-27
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
opdivoBiologic Licensing Application2025-06-30
opdivo qvantigBiologic Licensing Application2025-06-06
opdualagBiologic Licensing Application2024-03-01
Agency Specific
FDA
EMA
Expiration
Code
nivolumab, Opdivo, Bristol-Myers Squibb Company
2030-02-15Orphan excl.
nivolumab / relatlimab, Opdualag, Bristol-Myers Squibb Company
2029-03-18Orphan excl.
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
L01: Antineoplastic agents
L01F: Monoclonal antibodies and antibody drug conjugates
L01FF: Pd-1/pdl-1 (programmed cell death protein 1/death ligand 1) inhibitors
L01FF01: Nivolumab
HCPCS
Code
Description
J9299
Injection, nivolumab, 1 mg
Clinical
Clinical Trials
1912 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-small-cell lung carcinomaD002289376819118119
Renal cell carcinomaD002292EFO_0000376172982857
Lung neoplasmsD008175C34.901119711144
Kidney neoplasmsD007680EFO_0003865C643322414
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369C80787752115
MelanomaD00854536581918111
Colorectal neoplasmsD01517924293142
Squamous cell carcinoma of head and neckD00007719512203536
Neoplasm metastasisD009362EFO_000970813221132
Liver neoplasmsD008113EFO_1001513C22.015164128
CarcinomaD002277C80.081221027
Hepatocellular carcinomaD006528C22.013163126
AdenocarcinomaD00023012141325
Urinary bladder neoplasmsD001749C67914324
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pancreatic neoplasmsD010190EFO_0003860C25171926
Transitional cell carcinomaD0022951011219
Squamous cell carcinomaD002294310517
Triple negative breast neoplasmsD06472691314
Urologic neoplasmsD014571C64-C6879113
LymphomaD008223C85.9810113
Colonic neoplasmsD003110C186811
Ovarian neoplasmsD010051EFO_0003893C568810
Malignant mesotheliomaD00008600227210
SarcomaD012509378
Show 118 more
Indications Phases 1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Long term adverse effectsD00006945111
EncephalitisD00466011
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameNivolumab
INNnivolumab
Description
Nivolumab, sold under the brand name Opdivo, is a medication used to treat a number of types of cancer. This includes melanoma, lung cancer, renal cell carcinoma, Hodgkin lymphoma, head and neck cancer, colon cancer, and liver cancer. It is used by slow injection into a vein.
Classification
Antibody
Drug classmonoclonal antibodies
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
>5GGQ:H|nivolumab heavy chain QVQLVESGGGVVQPGRSLRLDCKASGITFSNSGMHWVRQAPGKGLEWVAVIWYDGSKRYYADSVKGRFTISRDNSKNTLF LQMNSLRAEDTAVYYCATNDDYWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALT SGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHHHHHH >5GGQ:L|nivolumab light chain EIVLTQSPATLSLSPGERATLSCRASQSVSSYLAWYQQKPGQAPRLLIYDASNRATGIPARFSGSGSGTDFTLTISSLEP EDFAVYYCQQSSNWPRTFGQGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQ ESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
Identifiers
PDB5GGQ, 5GGR, 5WT9
CAS-ID
RxCUI
ChEMBL IDCHEMBL2108738
ChEBI ID
PubChem CID
DrugBankDB09035
UNII ID31YO63LBSN (ChemIDplus, GSRS)
Target
Agency Approved
PDCD1
PDCD1
Organism
Homo sapiens
Gene name
PDCD1
Gene synonyms
PD1
NCBI Gene ID
Protein name
programmed cell death protein 1
Protein synonyms
CD279, programmed cell death 1 protein, protein PD-1, systemic lupus erythematosus susceptibility 2
Uniprot ID
Mouse ortholog
Pdcd1 (18566)
programmed cell death protein 1 (Q02242)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
£
Opdivo Bristol Myers Squibb
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Opdualag Bristol Myers Squibb
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 75,208 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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85,721 adverse events reported
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