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Libtayo(cemiplimab)
Libtayo (cemiplimab) is an antibody pharmaceutical. Cemiplimab was first approved as Libtayo on 2018-09-28. It is used to treat squamous cell carcinoma in the USA. It has been approved in Europe to treat squamous cell neoplasms. The pharmaceutical is active against programmed cell death protein 1.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
neoplasmsD009369
Trade Name
FDA
EMA
Libtayo
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)
Cemiplimab
Tradename
Proper name
Company
Number
Date
Products
Libtayocemiplimab-rwlcRegeneron PharmaceuticalsN-761097 RX2018-09-28
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
libtayoBiologic Licensing Application2021-02-22
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
squamous cell carcinoma—D002294—
Agency Specific
FDA
EMA
No data
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
— L01FF06: Cemiplimab
HCPCS
Code
Description
J9119
Injection, cemiplimab-rwlc, 1 mg
Clinical
Clinical Trials
104 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Squamous cell carcinomaD0022946141—321
Non-small-cell lung carcinomaD002289593—115
MelanomaD008545562——9
Squamous cell neoplasmsD018307231——6
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369C80199———20
Squamous cell carcinoma of head and neckD00007719569———12
Basal cell neoplasmsD01829512——14
Prostatic neoplasmsD011471C6133———4
Ovarian neoplasmsD010051EFO_0003893C5633———3
Pancreatic neoplasmsD010190EFO_0003860C2513———3
GlioblastomaD005909EFO_000051522———3
Merkel cell carcinomaD015266EFO_1001471C4A22———3
Multiple myelomaD009101C90.022———3
Head and neck neoplasmsD00625811———2
Show 26 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Lung neoplasmsD008175C34.901————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameCEMIPLIMAB
INNcemiplimab
Description
Cemiplimab, sold under the brand name Libtayo, is a monoclonal antibody medication for the treatment of squamous cell skin cancer. Cemiplimab belongs to a class of drugs that binds to the programmed death receptor-1 (PD-1), blocking the PD-1/PD-L1 pathway.
Classification
Antibody
Drug classmonoclonal antibodies
Image (chem structure or protein)CEMIPLIMAB
Structure (InChI/SMILES or Protein Sequence)
>7WVM:A,C|Heavy Chain of Cemiplimab EVQLLESGGVLVQPGGSLRLSCAASGFTFSNFGMTWVRQAPGKGLEWVSGISGGGRDTYFADSVKGRFTISRDNSKNTLY LQMNSLKGEDTAVYYCVKWGNIYFDYWGQGTLVTVSS >7WVM:B,D|Light Chain of Cemiplimab DIQMTQSPSSLSASVGDSITITCRASLSINTFLNWYQQKPGKAPNLLIYAASSLHGGVPSRFSGSGSGTDFTLTIRTLQP EDFATYYCQQSSNTPFTFGPGTVVDFR
Identifiers
PDB7WVM
CAS-ID—
RxCUI2058826
ChEMBL IDCHEMBL4297723
ChEBI ID—
PubChem CID—
DrugBankDB14707
UNII ID6QVL057INT (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
Clinical Variant
No data
Financial
Libtayo - Regeneron Pharmaceuticals
$
€
£
₣
Mock data
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 2,465 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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56,600 adverse events reported
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