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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Therapeutic Areas

Therapeutic Area	MeSH
neoplasms	D009369
digestive system diseases	D004066
respiratory tract diseases	D012140
urogenital diseases	D000091642
hemic and lymphatic diseases	D006425
immune system diseases	D007154

Trade Name

FDA

EMA

Opdivo

Combinations

Opdualag

Drug Products

FDA

EMA

Reference product - 351(a)

Interchangeable product - 351(k)

Biosimilar product - 351(k)

Nivolumab

Tradename	Proper name	Company	Number	Date	Products
Opdivo	nivolumab	Bristol-Myers Squibb Company	N-125554 RX	2014-12-22	4 products

Nivolumab

Relatlimab

Tradename	Proper name	Company	Number	Date	Products
Opdualag	nivolumab and relatlimab-rmbw	Bristol-Myers Squibb Company	N-761234 RX	2022-03-18	1 products

Labels

FDA

EMA

Brand Name	Status	Last Update
opdivo	Biologic Licensing Application	2021-01-22
opdualag	Biologic Licensing Application	2022-03-18

Indications

FDA

EMA

Indication	Ontology	MeSH	ICD-10
kidney neoplasms	EFO_0003865	D007680	C64
lymphoma	—	D008223	C85.9
melanoma	—	D008545	—
non-small-cell lung carcinoma	—	D002289	—
squamous cell carcinoma	—	D002294	—
urinary bladder neoplasms	—	D001749	C67

Agency Specific

FDA

EMA

Expiration	Code
nivolumab, Opdivo, Bristol-Myers Squibb Company
2030-02-15	Orphan excl.
nivolumab / relatlimab, Opdualag, Bristol-Myers Squibb Company
2029-03-18	Orphan 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

1411 clinical trials

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Indications Phases 4

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Melanoma	D008545			89	119	22	2	8	201
Non-small-cell lung carcinoma	D002289			84	127	23	2	4	196
Renal cell carcinoma	D002292			57	74	11	2	1	118
Liver neoplasms	D008113	EFO_1001513	C22.0	31	44	6	1	2	66
Lung neoplasms	D008175		C34.90	18	30	8	2	2	50
Kidney neoplasms	D007680	EFO_0003865	C64	6	11	—	2	2	19

Indications Phases 3

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Neoplasms	D009369		C80	135	109	4	—	2	183
Colorectal neoplasms	D015179			36	48	4	—	1	71
Squamous cell carcinoma of head and neck	D000077195			32	41	4	—	4	68
Hodgkin disease	D006689		C81	20	31	2	—	—	42
Breast neoplasms	D001943	EFO_0003869	C50	16	20	1	—	1	35
Stomach neoplasms	D013274	EFO_0003897	C16	14	20	7	—	—	34
Head and neck neoplasms	D006258			14	20	4	—	1	32
Prostatic neoplasms	D011471		C61	10	25	1	—	—	30
Urinary bladder neoplasms	D001749		C67	10	19	3	—	—	30
Urologic neoplasms	D014571		C64-C68	17	18	1	—	—	28

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Indications Phases 2

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Pancreatic neoplasms	D010190	EFO_0003860	C25	32	33	—	—	—	53
Ovarian neoplasms	D010051	EFO_0003893	C56	21	19	—	—	—	31
Small cell lung carcinoma	D055752			13	19	—	—	—	24
Triple negative breast neoplasms	D064726			16	10	—	—	—	19
Castration-resistant prostatic neoplasms	D064129			9	10	—	—	—	17
Large b-cell lymphoma diffuse	D016403		C83.3	12	8	—	—	—	16
Uveal neoplasms	D014604	EFO_1001230		9	10	—	—	—	16
Hepatocellular carcinoma	D006528		C22.0	8	11	—	—	—	15
Uterine cervical neoplasms	D002583			6	10	—	—	1	14
Lymphoma	D008223		C85.9	8	7	—	—	—	13

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Indications Phases 1

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Kaposi sarcoma	D012514		C46	4	—	—	—	—	4
Bcr-abl positive chronic myelogenous leukemia	D015464	EFO_0000340		3	—	—	—	—	3
Anemia	D000740	EFO_0004272	D64.9	2	—	—	—	—	2
Psoriasis	D011565	EFO_0000676	L40	2	—	—	—	—	2
Ulcerative colitis	D003093	EFO_0000729	K51	2	—	—	—	—	2
Rheumatoid arthritis	D001172	EFO_0000685	M06.9	2	—	—	—	—	2
Multiple sclerosis	D009103	EFO_0003885	G35	2	—	—	—	—	2
Crohn disease	D003424	EFO_0000384	K50	2	—	—	—	—	2
Autoimmune diseases	D001327	EFO_0000540	M30-M36	2	—	—	—	—	2
Systemic lupus erythematosus	D008180	EFO_0002690	M32	2	—	—	—	—	2

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Indications Without Phase

Indication	MeSH	Ontology	ICD-10	Ph 1	Ph 2	Ph 3	Ph 4	Other	Total
Liver diseases	D008107	EFO_0001421	K70-K77	—	—	—	—	1	1
Dna damage	D004249			—	—	—	—	1	1
Double-stranded dna breaks	D053903			—	—	—	—	1	1
Encephalitis	D004660			—	—	—	—	1	1

Epidemiology

Epidemiological information for investigational and approved indications

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Drug

General

Drug common name	NIVOLUMAB
INN	nivolumab
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 class	monoclonal antibodies
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)	>5GGQ:H\|nivolumab heavy chain QVQLVESGGGVVQPGRSLRLDCKASGITFSNSGMHWVRQAPGKGLEWVAVIWYDGSKRYYADSVKGRFTISRDNSKNTLF LQMNSLRAEDTAVYYCATNDDYWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALT SGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHHHHHH >5GGQ:L\|nivolumab light chain EIVLTQSPATLSLSPGERATLSCRASQSVSSYLAWYQQKPGQAPRLLIYDASNRATGIPARFSGSGSGTDFTLTISSLEP EDFAVYYCQQSSNWPRTFGQGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQ ESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC

Identifiers

PDB	5GGQ, 5GGR, 5WT9
CAS-ID	946414-94-4
RxCUI	1597876
ChEMBL ID	CHEMBL2108738
ChEBI ID	—
PubChem CID	—
DrugBank	DB09035
UNII ID	31YO63LBSN (ChemIDplus, GSRS)

Target

Agency Approved

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

Clinical Variant

No data

Financial

Opdivo - Bristol Myers Squibb

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Opdualag - Bristol Myers Squibb

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Trends

PubMed Central

Top Terms for Disease or Syndrome:

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Additional graphs summarizing 48,178 documents

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Safety

Black-box Warning

No Black-box warning

Adverse Events

Top Adverse Reactions

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424 adverse events reported

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Real-time Data on

Companies, Drugs, and Diseases

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MATERIALS

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