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
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 |
|---|---|---|---|---|---|
| Libtayo | cemiplimab-rwlc | Regeneron Pharmaceuticals | N-761097 RX | 2018-09-28 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| libtayo | Biologic Licensing Application | 2024-06-05 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| squamous cell carcinoma | — | D002294 | — |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J9119 | Injection, cemiplimab-rwlc, 1 mg |
Clinical
Clinical Trials
199 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Non-small-cell lung carcinoma | D002289 | — | — | 5 | 18 | 7 | — | 2 | 26 |
| Squamous cell carcinoma | D002294 | — | — | 5 | 13 | 1 | — | 3 | 21 |
| Carcinoma | D002277 | — | C80.0 | 5 | 14 | 1 | — | 1 | 19 |
| Melanoma | D008545 | — | — | 3 | 7 | 3 | — | — | 12 |
| Lung neoplasms | D008175 | — | C34.90 | 2 | 6 | 5 | — | — | 11 |
| Squamous cell neoplasms | D018307 | — | — | 2 | 1 | 1 | — | — | 4 |
| Skin neoplasms | D012878 | EFO_0004198 | C44 | 1 | 2 | 1 | — | — | 4 |
| Uterine cervical neoplasms | D002583 | — | — | 1 | 2 | 1 | — | — | 3 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 12 | 8 | — | — | — | 15 |
| Squamous cell carcinoma of head and neck | D000077195 | — | — | 3 | 9 | — | — | — | 12 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 5 | 4 | — | — | — | 6 |
| Prostatic neoplasms | D011471 | — | C61 | 5 | 4 | — | — | — | 6 |
| Basal cell carcinoma | D002280 | — | — | 1 | 3 | — | — | 1 | 5 |
| Basal cell neoplasms | D018295 | — | — | 1 | 3 | — | — | 1 | 5 |
| Recurrence | D012008 | — | — | 3 | 3 | — | — | — | 4 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 1 | 3 | — | — | — | 4 |
| Fallopian tube neoplasms | D005185 | — | — | 3 | 3 | — | — | — | 4 |
| Colorectal neoplasms | D015179 | — | — | 1 | 3 | — | — | — | 4 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Glioblastoma | D005909 | EFO_0000515 | — | 1 | — | — | — | — | 1 |
| Follicular lymphoma | D008224 | — | C82 | 1 | — | — | — | — | 1 |
| Multiple myeloma | D009101 | — | C90.0 | 1 | — | — | — | — | 1 |
| Anaplastic thyroid carcinoma | D065646 | — | — | 1 | — | — | — | — | 1 |
| Thyroid diseases | D013959 | — | E00-E07 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Cemiplimab |
| INN | cemiplimab |
| 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 class | monoclonal antibodies |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | >8GY5:A,H|heavy chain
EVQLLESGGVLVQPGGSLRLSCAASGFTFSNFGMTWVRQAPGKGLEWVSGISGGGRDTYFADSVKGRFTISRDNSKNTLY
LQMNSLKGEDTAVYYCVKWGNIYFDYWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNS
GALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHHHHHH
>8GY5:B,L|light chain
DIQMTQSPSSLSASVGDSITITCRASLSINTFLNWYQQKPGKAPNLLIYAASSLHGGVPSRFSGSGSGTDFTLTIRTLQP
EDFATYYCQQSSNTPFTFGPGTVVDFRRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQ
ESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC |
Identifiers
| PDB | 7WVM, 8GY5 |
| CAS-ID | — |
| RxCUI | 2058826 |
| ChEMBL ID | CHEMBL4297723 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB14707 |
| UNII ID | 6QVL057INT (ChemIDplus, GSRS) |
Target
Agency Approved
PDCD1
PDCD1
Alternate
No data
Variants
No data
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Libtayo – Regeneron Pharmaceuticals
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Trends
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Safety
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Adverse Events
Top Adverse Reactions
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2,546 adverse events reported
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