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Drug ReportsPembrolizumab
Keytruda(pembrolizumab)
Keytruda (pembrolizumab) is an antibody pharmaceutical. Pembrolizumab was first approved as Keytruda on 2014-09-04. It is used to treat hodgkin disease, melanoma, microsatellite instability, non-small-cell lung carcinoma, and squamous cell carcinoma amongst others in the USA. It has been approved in Europe to treat endometrial neoplasms, hodgkin disease, melanoma, non-small-cell lung carcinoma, and renal cell 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
respiratory tract diseasesD012140
urogenital diseasesD000091642
hemic and lymphatic diseasesD006425
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
genetic phenomenaD055614
Trade Name
FDA
EMA
Keytruda (discontinued: Keytruda)
Combinations
Keytruda qlex
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)
Pembrolizumab
Tradename
Proper name
Company
Number
Date
Products
KeytrudapembrolizumabMerck & CoN-125514 RX2015-01-15
1 products
Show 1 discontinued
Berahyaluronidase alfa
+
Pembrolizumab
Tradename
Proper name
Company
Number
Date
Products
Keytruda Qlexpembrolizumab and berahyaluronidase alfa-pmphMerck & CoN-761467 RX2025-09-19
2 products
Labels
FDA
EMA
Brand Name
Status
Last Update
keytrudaBiologic Licensing Application2025-08-19
keytruda qlexBiologic Licensing Application2025-11-21
Agency Specific
FDA
EMA
Expiration
Code
pembrolizumab, Keytruda, Merck Sharp & Dohme LLC
2028-12-03Orphan 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
L01FF02: Pembrolizumab
HCPCS
Code
Description
J9271
Injection, pembrolizumab, 1 mg
Clinical
Clinical Trials
2747 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 carcinomaD002289258296115349601
NeoplasmsD009369C8038623113219503
CarcinomaD002277C80.013623337121366
MelanomaD00854517719128136353
Squamous cell carcinoma of head and neckD00007719512216426111267
Breast neoplasmsD001943EFO_0003869C5010315016111237
Triple negative breast neoplasmsD064726861141315185
Renal cell carcinomaD002292EFO_000037683831316149
AdenocarcinomaD0002304183421115
Pancreatic neoplasmsD010190EFO_0003860C25635311297
Show 12 more
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Lung neoplasmsD008175C34.901261594434299
Squamous cell carcinomaD00229471118177180
Colorectal neoplasmsD01517910791810174
Neoplasm metastasisD009362EFO_00097088072145134
Head and neck neoplasmsD0062585380155122
Stomach neoplasmsD013274EFO_0003897C165968123113
Ovarian neoplasmsD010051EFO_0003893C56617042109
Hepatocellular carcinomaD006528C22.03952919100
Liver neoplasmsD008113EFO_1001513C22.03851101496
RecurrenceD01200831724492
Show 75 more
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Non-hodgkin lymphomaD008228C85.9222234
B-cell lymphomaD0163931720133
Large b-cell lymphoma diffuseD016403C83.3162030
Castration-resistant prostatic neoplasmsD064129121323
Pancreatic ductal carcinomaD021441131521
Microsatellite instabilityD053842111320
T-cell lymphomaD01639991720
Follicular lymphomaD008224C82121320
LeukemiaD007938C9598117
Myeloid leukemia acuteD015470C92.09916
Show 193 more
Indications Phases 1
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common namePembrolizumab
INNpembrolizumab
Description
Pembrolizumab (formerly lambrolizumab, brand name Keytruda) is a humanized antibody used in cancer immunotherapy. This includes to treat melanoma, lung cancer, head and neck cancer, Hodgkin lymphoma, and stomach cancer. It is given by slow injection into a vein.
Classification
Antibody
Drug classmonoclonal antibodies
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
>5GGS:A,C|heavy chain QVQLVQSGVEVKKPGASVKVSCKASGYTFTNYYMYWVRQAPGQGLEWMGGINPSNGGTNFNEKFKNRVTLTTDSSTTTAY MELKSLQFDDTAVYYCARRDYRFDMGFDYWGQGTTVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVS WNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHHHHHH >5GGS:B,D|light chain EIVLTQSPATLSLSPGERATLSCRASKGVSTSGYSYLHWYQQKPGQAPRLLIYLASYLESGVPARFSGSGSGTDFTLTIS SLEPEDFAVYYCQHSRDLPLTFGGGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQS GNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
Identifiers
PDB5B8C, 5DK3, 5GGS, 5JXE
CAS-ID
RxCUI
ChEMBL IDCHEMBL3137343
ChEBI ID
PubChem CID
DrugBankDB09037
UNII IDDPT0O3T46P (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
$
£
Keytruda Merck & Co
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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 81,956 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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77,251 adverse events reported
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