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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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Clinical
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Financial
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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
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
1801 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
CarcinomaD002277C80.013421936141375
MelanomaD00854512817838347335
NeoplasmsD009369C802061588216301
Non-small-cell lung carcinomaD00228910515331444286
Lung neoplasmsD008175HP_0100526C34.907512831431232
Renal cell carcinomaD002292EFO_0000376689614226176
Liver neoplasmsD008113EFO_1001513C22.03753811190
Kidney neoplasmsD007680EFO_0003865C641021221344
OncogenesD009857112
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
LymphomaD008223C85.9517162109
Squamous cell carcinomaD00229431571414105
AdenocarcinomaD000230376110898
Colorectal neoplasmsD01517947644796
Squamous cell carcinoma of head and neckD000077195384991496
Hepatocellular carcinomaD006528C22.0375751391
RecurrenceD01200835455179
Neoplasm metastasisD009362EFO_000970838353569
Stomach neoplasmsD013274EFO_0003897C16233413865
Hodgkin diseaseD006689C8123394255
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Pancreatic neoplasmsD010190EFO_0003860C25393360
Triple negative breast neoplasmsD064726191627
GliomaD005910EFO_00005201112119
Large b-cell lymphoma diffuseD016403C83.3121119
Hematologic neoplasmsD01933712817
Rectal neoplasmsD01200461417
Castration-resistant prostatic neoplasmsD0641299916
Endometrial neoplasmsD016889EFO_000423081216
Neuroendocrine carcinomaD01827841114
Neuroendocrine tumorsD018358EFO_1001901D3A.811314
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Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
MyocarditisD009205I51.433
Heart diseasesD006331EFO_0003777I51.922
MicrobiotaD06430722
MetagenomeD05489222
Multiple primary neoplasmsD00937822
Cardiovascular diseasesD002318HP_000162611
CardiomyopathiesD009202EFO_0000318I4211
PericarditisD010493EFO_0007427I3011
VasculitisD014657HP_000263311
High-throughput nucleotide sequencingD05901411
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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
$
£
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 64,135 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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78,053 adverse events reported
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