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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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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
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
Labels
FDA
EMA
Brand Name
Status
Last Update
opdivoBiologic Licensing Application2024-10-03
opdivo qvantigBiologic Licensing Application2024-12-27
opdualagBiologic Licensing Application2024-03-01
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
non-small-cell lung carcinoma—D002289—
lymphoma—D008223C85.9
urinary bladder neoplasms—D001749C67
melanoma—D008545—
kidney neoplasmsEFO_0003865D007680C64
squamous cell carcinoma—D002294—
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
1825 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
CarcinomaD002277—C80.0347315116123
NeoplasmsD009369—C808082311119
Non-small-cell lung carcinomaD002289——296219116108
Lung neoplasmsD008175HP_0100526C34.90235821214104
Renal cell carcinomaD002292EFO_0000376—153082857
Kidney neoplasmsD007680EFO_0003865C6425—2412
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
MelanomaD008545——386020—16114
Colorectal neoplasmsD015179——21293—140
AdenocarcinomaD000230——20261—339
Squamous cell carcinomaD002294——7226—739
Squamous cell carcinoma of head and neckD000077195——11205—638
LymphomaD008223—C85.920261—135
Prostatic neoplasmsD011471—C618232——28
Hepatocellular carcinomaD006528—C22.014163—126
Liver neoplasmsD008113EFO_1001513C22.013164—126
RecurrenceD012008——7144——22
Show 23 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pancreatic neoplasmsD010190EFO_0003860C251618———25
Transitional cell carcinomaD002295——810——216
SarcomaD012509——612———13
Urologic neoplasmsD014571—C64-C6879——113
Triple negative breast neoplasmsD064726——611———12
B-cell lymphomaD016393——67———9
Colonic neoplasmsD003110—C1846———8
Large b-cell lymphoma diffuseD016403—C83.346———8
GliomaD005910EFO_0000520—55———8
Castration-resistant prostatic neoplasmsD064129——25———7
Show 115 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
AstrocytomaD001254EFO_0000271—2————2
Glandular and epithelial neoplasmsD009375——2————2
MyoepitheliomaD009208——2————2
Bcr-abl positive chronic myelogenous leukemiaD015464EFO_0000340—1————1
NeurofibrosarcomaD018319——1————1
Nerve sheath neoplasmsD018317EFO_0000760—1————1
Fallopian tube diseasesD005184EFO_0009548N831————1
Central nervous system neoplasmsD016543——1————1
Gata2 deficiencyD000077428—D46.221————1
Neoplasms by histologic typeD009370——1————1
Show 21 more
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Long term adverse effectsD000069451——————11
EncephalitisD004660HP_0002383—————11
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
5133
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
Q8IX89
Mouse ortholog
Pdcd1 (18566)
programmed cell death protein 1 (Q02242)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
Opdualag – Bristol Myers Squibb
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Opdivo – 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 66,175 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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82,858 adverse events reported
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