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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Commercial
Trade Name
FDA
EMA
Keytruda
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 |
---|---|---|---|---|---|
Keytruda | pembrolizumab | Merck Sharp & Dohme | N-125514 RX | 2015-01-15 | 1 products |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
keytruda | Biologic Licensing Application | 2021-03-16 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
Expiration | Code | ||
---|---|---|---|
pembrolizumab, Keytruda, Merck Sharp & Dohme LLC | |||
2028-12-03 | Orphan excl. |
Patent Expiration
No data
HCPCS
Code | Description |
---|---|
J9271 | Injection, pembrolizumab, 1 mg |
Clinical
Clinical Trials
1871 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 carcinoma | D002289 | 146 | 180 | 58 | 2 | 9 | 334 | ||
Melanoma | D008545 | 116 | 124 | 15 | 1 | 10 | 211 | ||
Squamous cell carcinoma of head and neck | D000077195 | 66 | 98 | 5 | 1 | 4 | 149 | ||
Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 39 | 37 | 1 | 1 | — | 66 |
Glioblastoma | D005909 | EFO_0000515 | 14 | 22 | — | 1 | 1 | 31 | |
Thymoma | D013945 | 1 | — | — | 1 | — | 2 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Neoplasms | D009369 | C80 | 215 | 125 | 2 | — | 3 | 264 | |
Breast neoplasms | D001943 | EFO_0003869 | C50 | 58 | 82 | 6 | — | 2 | 126 |
Colorectal neoplasms | D015179 | 63 | 64 | 6 | — | 2 | 109 | ||
Triple negative breast neoplasms | D064726 | 50 | 60 | 7 | — | — | 99 | ||
Renal cell carcinoma | D002292 | 58 | 50 | 6 | — | 4 | 93 | ||
Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 39 | 54 | 3 | — | 1 | 80 |
Stomach neoplasms | D013274 | EFO_0003897 | C16 | 39 | 46 | 6 | — | — | 74 |
Head and neck neoplasms | D006258 | 30 | 48 | 9 | — | — | 71 | ||
Lung neoplasms | D008175 | C34.90 | 34 | 40 | 11 | — | 3 | 67 | |
Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 28 | 35 | 6 | — | 4 | 64 |
Show 43 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Sarcoma | D012509 | 15 | 22 | — | — | — | 28 | ||
Lymphoma | D008223 | C85.9 | 19 | 11 | — | — | — | 24 | |
Non-hodgkin lymphoma | D008228 | C85.9 | 16 | 14 | — | — | — | 23 | |
Large b-cell lymphoma diffuse | D016403 | C83.3 | 12 | 15 | — | — | — | 23 | |
Castration-resistant prostatic neoplasms | D064129 | 10 | 13 | — | — | — | 20 | ||
Cholangiocarcinoma | D018281 | C22.1 | 11 | 12 | — | — | — | 18 | |
Follicular lymphoma | D008224 | C82 | 11 | 10 | — | — | — | 17 | |
Myeloid leukemia acute | D015470 | C92.0 | 9 | 9 | — | — | — | 16 | |
Pancreatic ductal carcinoma | D021441 | 3 | 10 | — | — | — | 11 | ||
Hepatocellular carcinoma | D006528 | C22.0 | 5 | 8 | — | — | — | 10 |
Show 126 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Lymphoid leukemia | D007945 | C91 | 2 | — | — | — | — | 2 | |
Hiv infections | D015658 | EFO_0000764 | B20 | 2 | — | — | — | — | 2 |
Digestive system neoplasms | D004067 | 2 | — | — | — | — | 2 | ||
Bcr-abl positive chronic myelogenous leukemia | D015464 | EFO_0000340 | 1 | — | — | — | — | 1 | |
Myelomonocytic leukemia chronic | D015477 | C93.1 | 1 | — | — | — | — | 1 | |
Anemia | D000740 | EFO_0004272 | D64.9 | 1 | — | — | — | — | 1 |
Leukemia myeloid chronic atypical bcr-abl negative | D054438 | C92.2 | 1 | — | — | — | — | 1 | |
Thrombocytosis | D013922 | D75.83 | 1 | — | — | — | — | 1 | |
B-cell leukemia | D015448 | 1 | — | — | — | — | 1 | ||
Pharmacokinetics | D010599 | 1 | — | — | — | — | 1 |
Show 16 more
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 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | PEMBROLIZUMAB |
INN | pembrolizumab |
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 class | monoclonal antibodies |
Image (chem structure or protein) | |
Structure (InChI/SMILES or Protein Sequence) | >5GGS:A,C|heavy chain
QVQLVQSGVEVKKPGASVKVSCKASGYTFTNYYMYWVRQAPGQGLEWMGGINPSNGGTNFNEKFKNRVTLTTDSSTTTAY
MELKSLQFDDTAVYYCARRDYRFDMGFDYWGQGTTVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVS
WNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHHHHHH
>5GGS:B,D|light chain
EIVLTQSPATLSLSPGERATLSCRASKGVSTSGYSYLHWYQQKPGQAPRLLIYLASYLESGVPARFSGSGSGTDFTLTIS
SLEPEDFAVYYCQHSRDLPLTFGGGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQS
GNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC |
Identifiers
PDB | 5B8C, 5DK3, 5GGS, 5JXE |
CAS-ID | 1374853-91-4 |
RxCUI | 1547545 |
ChEMBL ID | CHEMBL3137343 |
ChEBI ID | — |
PubChem CID | — |
DrugBank | DB09037 |
UNII ID | DPT0O3T46P (ChemIDplus, GSRS) |
Target
Agency Approved
PDCD1
PDCD1
Alternate
No data
Variants
Clinical Variant
No data
Financial
Keytruda - Merck Sharp & Dohme
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 47,111 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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2,697 adverse events reported
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