Bavencio(avelumab)
Bavencio (avelumab) is an antibody pharmaceutical. Avelumab was first approved as Bavencio on 2017-03-23. It is used to treat merkel cell carcinoma and transitional cell carcinoma in the USA. It has been approved in Europe to treat neuroendocrine tumors. The pharmaceutical is active against programmed cell death 1 ligand 1.
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Commercial
Trade Name
FDA
EMA
Bavencio
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)
Avelumab
Tradename | Proper name | Company | Number | Date | Products |
|---|---|---|---|---|---|
| Bavencio | avelumab | EMD Serono | N-761049 RX | 2017-03-23 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| bavencio | Biologic Licensing Application | 2020-11-17 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| merkel cell carcinoma | EFO_1001471 | D015266 | C4A |
| transitional cell carcinoma | — | D002295 | — |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
avelumab, Bavencio, EMD Serono, Inc. | |||
| 2024-03-23 | Orphan excl. | ||
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J9023 | Injection, avelumab, 10 mg |
Clinical
Clinical Trials
248 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 |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | C80 | 21 | 17 | 2 | — | — | 34 | |
| Non-small-cell lung carcinoma | D002289 | 15 | 16 | 3 | — | — | 25 | ||
| Urologic neoplasms | D014571 | C64-C68 | 7 | 10 | 1 | — | 4 | 20 | |
| Renal cell carcinoma | D002292 | 4 | 8 | 1 | — | 5 | 17 | ||
| Merkel cell carcinoma | D015266 | EFO_1001471 | C4A | 5 | 12 | 1 | — | 1 | 14 |
| Urinary bladder neoplasms | D001749 | C67 | 3 | 8 | 1 | — | 2 | 11 | |
| Squamous cell carcinoma of head and neck | D000077195 | 6 | 3 | 2 | — | — | 9 | ||
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 4 | 1 | 4 | — | — | 8 |
| Triple negative breast neoplasms | D064726 | 4 | 5 | 1 | — | — | 7 | ||
| Adenocarcinoma | D000230 | — | 4 | 1 | — | — | 5 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Colorectal neoplasms | D015179 | 6 | 15 | — | — | — | 17 | ||
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 5 | 10 | — | — | — | 13 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 8 | 8 | — | — | — | 10 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 3 | 5 | — | — | — | 6 |
| Castration-resistant prostatic neoplasms | D064129 | 4 | 4 | — | — | — | 5 | ||
| Glioblastoma | D005909 | EFO_0000515 | 2 | 4 | — | — | — | 5 | |
| Prostatic neoplasms | D011471 | C61 | 3 | 4 | — | — | — | 4 | |
| Head and neck neoplasms | D006258 | 3 | 2 | — | — | — | 4 | ||
| Squamous cell neoplasms | D018307 | 1 | 4 | — | — | — | 4 | ||
| Myeloid leukemia acute | D015470 | C92.0 | 4 | 3 | — | — | — | 4 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sezary syndrome | D012751 | C84.1 | 1 | — | — | — | — | 1 | |
| Large-cell lymphoma anaplastic | D017728 | C84.6 | 1 | — | — | — | — | 1 | |
| T-cell lymphoma peripheral | D016411 | C84.9 | 1 | — | — | — | — | 1 | |
| Mycosis fungoides | D009182 | C84.0 | 1 | — | — | — | — | 1 | |
| Glioma | D005910 | EFO_0000520 | 1 | — | — | — | — | 1 | |
| Follicular lymphoma | D008224 | C82 | 1 | — | — | — | — | 1 | |
| Pancreatic ductal carcinoma | D021441 | 1 | — | — | — | — | 1 | ||
| Lymphoma | D008223 | C85.9 | 1 | — | — | — | — | 1 | |
| Mantle-cell lymphoma | D020522 | C83.1 | 1 | — | — | — | — | 1 | |
| Meningioma | D008579 | EFO_0003098 | D32.9 | 1 | — | — | — | — | 1 |
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Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | AVELUMAB |
| INN | avelumab |
| Description | Avelumab, sold under the brand name Bavencio, is a fully human monoclonal antibody medication for the treatment of Merkel cell carcinoma, urothelial carcinoma, and renal cell carcinoma.
|
| Classification | Antibody |
| Drug class | monoclonal antibodies |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | 5GRJ |
| CAS-ID | 1537032-82-8 |
| RxCUI | 1875534 |
| ChEMBL ID | CHEMBL3833373 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB11945 |
| UNII ID | KXG2PJ551I (ChemIDplus, GSRS) |
Target
Agency Approved
CD274
CD274
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 8,722 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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655 adverse events reported
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