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
160 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 |
|---|---|---|---|---|---|---|---|---|---|
| Carcinoma | D002277 | — | C80.0 | 13 | 27 | 6 | — | 2 | 44 |
| Non-small-cell lung carcinoma | D002289 | — | — | 12 | 31 | 7 | — | 3 | 40 |
| Squamous cell carcinoma | D002294 | — | — | 13 | 24 | 3 | — | 4 | 39 |
| Neoplasms | D009369 | — | C80 | 27 | 16 | 1 | — | 2 | 34 |
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | 6 | 15 | 6 | — | 2 | 23 |
| Melanoma | D008545 | — | — | 9 | 13 | 5 | — | — | 20 |
| Squamous cell carcinoma of head and neck | D000077195 | — | — | 7 | 13 | 2 | — | — | 19 |
| Squamous cell neoplasms | D018307 | — | — | 3 | 4 | 2 | — | — | 9 |
| Recurrence | D012008 | — | — | 5 | 4 | 1 | — | — | 9 |
| Colorectal neoplasms | D015179 | — | — | 3 | 6 | 1 | — | — | 7 |
Show 8 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Skin neoplasms | D012878 | EFO_0004198 | C44 | 3 | 6 | — | — | — | 8 |
| Prostatic neoplasms | D011471 | — | C61 | 7 | 7 | — | — | — | 8 |
| Head and neck neoplasms | D006258 | — | — | 4 | 6 | — | — | — | 7 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 3 | 6 | — | — | — | 7 |
| Lymphoma | D008223 | — | C85.9 | 4 | 3 | — | — | — | 6 |
| Basal cell carcinoma | D002280 | — | — | 1 | 4 | — | — | 1 | 6 |
| Basal cell neoplasms | D018295 | — | — | 1 | 4 | — | — | 1 | 6 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 6 | 5 | — | — | — | 6 |
| Sarcoma | D012509 | — | — | 1 | 5 | — | — | — | 5 |
| Triple negative breast neoplasms | D064726 | — | — | 2 | 4 | — | — | — | 5 |
Show 49 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 3 | — | — | — | — | 3 |
| Large-cell lymphoma anaplastic | D017728 | — | C84.6 | 2 | — | — | — | — | 2 |
| Leukemia | D007938 | — | C95 | 1 | — | — | — | — | 1 |
| Myelodysplastic syndromes | D009190 | — | D46 | 1 | — | — | — | — | 1 |
| Myeloid leukemia acute | D015470 | — | C92.0 | 1 | — | — | — | — | 1 |
| B-cell lymphoma | D016393 | — | — | 1 | — | — | — | — | 1 |
| Immunoblastic lymphadenopathy | D007119 | EFO_1001350 | C86.5 | 1 | — | — | — | — | 1 |
| Myeloid leukemia | D007951 | — | C92 | 1 | — | — | — | — | 1 |
| Preleukemia | D011289 | — | — | 1 | — | — | — | — | 1 |
| Syndrome | D013577 | — | — | 1 | — | — | — | — | 1 |
Show 6 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myocarditis | D009205 | — | I51.4 | — | — | — | — | 1 | 1 |
| Immune system diseases | D007154 | — | D89.9 | — | — | — | — | 1 | 1 |
| Inflammation | D007249 | MP_0001845 | — | — | — | — | — | 1 | 1 |
| Autoimmune diseases | D001327 | HP_0002960 | M30-M36 | — | — | — | — | 1 | 1 |
| Erectile dysfunction | D007172 | EFO_0004234 | F52.21 | — | — | — | — | 1 | 1 |
| Eunuchism | D005058 | EFO_0007266 | E29.1 | — | — | — | — | 1 | 1 |
| Hypogonadism | D007006 | HP_0000044 | E23.0 | — | — | — | — | 1 | 1 |
| Physiological sexual dysfunction | D012735 | — | — | — | — | — | — | 1 | 1 |
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
Financial
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Libtayo – Regeneron Pharmaceuticals
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Estimated US medical usage
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Trends
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Safety
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Adverse Events
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1,858 adverse events reported
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