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
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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
200 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 | — | — | 14 | 38 | 11 | — | 4 | 54 |
| Neoplasms | D009369 | — | C80 | 28 | 21 | 1 | — | 2 | 39 |
| Squamous cell carcinoma | D002294 | — | — | 11 | 22 | 2 | — | 4 | 35 |
| Carcinoma | D002277 | — | C80.0 | 8 | 27 | 1 | — | 1 | 33 |
| Squamous cell carcinoma of head and neck | D000077195 | — | — | 7 | 17 | 1 | — | — | 22 |
| Melanoma | D008545 | — | — | 10 | 14 | 4 | — | — | 22 |
| Lung neoplasms | D008175 | — | C34.90 | 3 | 12 | 5 | — | 1 | 18 |
| Skin neoplasms | D012878 | EFO_0004198 | C44 | 6 | 7 | 1 | — | — | 13 |
| Colorectal neoplasms | D015179 | — | — | 4 | 7 | 1 | — | — | 9 |
| Squamous cell neoplasms | D018307 | — | — | 3 | 4 | 1 | — | — | 8 |
Show 12 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 6 | 5 | — | — | — | 10 |
| Head and neck neoplasms | D006258 | — | — | 5 | 7 | — | — | — | 9 |
| Prostatic neoplasms | D011471 | — | C61 | 8 | 7 | — | — | — | 9 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 4 | 7 | — | — | — | 9 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 7 | 6 | — | — | — | 8 |
| Basal cell neoplasms | D018295 | — | — | 1 | 5 | — | — | 1 | 7 |
| Recurrence | D012008 | — | — | 5 | 5 | — | — | — | 7 |
| Basal cell carcinoma | D002280 | — | — | 1 | 4 | — | — | 1 | 6 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | 3 | 5 | — | — | — | 6 |
| Sarcoma | D012509 | — | — | 1 | 5 | — | — | — | 5 |
Show 60 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 | 2 | — | — | — | — | 2 |
| Large-cell lymphoma anaplastic | D017728 | — | C84.6 | 2 | — | — | — | — | 2 |
| Follicular lymphoma | D008224 | — | C82 | 2 | — | — | — | — | 2 |
| 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 |
| Motor activity | D009043 | EFO_0003940 | — | 1 | — | — | — | — | 1 |
| Carcinoma in situ | D002278 | — | D09.9 | 1 | — | — | — | — | 1 |
| Mantle-cell lymphoma | D020522 | — | C83.1 | 1 | — | — | — | — | 1 |
Show 2 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Immunotherapy | D007167 | — | — | — | — | — | — | 2 | 2 |
| Myocarditis | D009205 | — | I51.4 | — | — | — | — | 1 | 1 |
| Immune system diseases | D007154 | — | D89.9 | — | — | — | — | 1 | 1 |
| Inflammation | D007249 | MP_0001845 | — | — | — | — | — | 1 | 1 |
| Autoimmune diseases | D001327 | EFO_0000540 | M30-M36 | — | — | — | — | 1 | 1 |
| Erectile dysfunction | D007172 | EFO_0004234 | F52.21 | — | — | — | — | 1 | 1 |
| Eunuchism | D005058 | EFO_0007266 | E29.1 | — | — | — | — | 1 | 1 |
| Physiological sexual dysfunction | D012735 | — | — | — | — | — | — | 1 | 1 |
| Neoadjuvant therapy | D020360 | — | — | — | — | — | — | 1 | 1 |
| Female genital neoplasms | D005833 | — | — | — | — | — | — | 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
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Libtayo – Regeneron Pharmaceuticals
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Trends
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Safety
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Adverse Events
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2,546 adverse events reported
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