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
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| infections | D007239 |
| neoplasms | D009369 |
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 | 2025-06-13 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| transitional cell carcinoma | — | D002295 | — |
| merkel cell carcinoma | EFO_1001471 | D015266 | C4A |
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
296 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 |
|---|---|---|---|---|---|---|---|---|---|
| Merkel cell carcinoma | D015266 | EFO_1001471 | C4A | 1 | 2 | 1 | — | — | 3 |
| Lymphoma | D008223 | — | C85.9 | — | — | 1 | — | — | 1 |
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | — | — | 1 | — | — | 1 |
| B-cell lymphoma | D016393 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Carcinoma | D002277 | — | C80.0 | 1 | 3 | — | — | — | 4 |
| Urinary bladder neoplasms | D001749 | — | C67 | 2 | 2 | — | — | — | 3 |
| Adenocarcinoma | D000230 | — | — | — | 2 | — | — | — | 2 |
| Squamous cell carcinoma | D002294 | — | — | — | 2 | — | — | — | 2 |
| Prostatic neoplasms | D011471 | — | C61 | 1 | 2 | — | — | — | 2 |
| Non-small-cell lung carcinoma | D002289 | — | — | 2 | 1 | — | — | — | 2 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | 1 | — | — | — | 1 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | — | 1 | — | — | — | 1 |
| Anus neoplasms | D001005 | EFO_0003835 | C21 | — | 1 | — | — | — | 1 |
| Virus diseases | D014777 | — | B34 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Urologic neoplasms | D014571 | — | C64-C68 | 1 | — | — | — | — | 1 |
| Urethral neoplasms | D014523 | EFO_0003846 | — | 1 | — | — | — | — | 1 |
| Transitional cell carcinoma | D002295 | — | — | 1 | — | — | — | — | 1 |
| Ureteral neoplasms | D014516 | EFO_0003844 | C66 | 1 | — | — | — | — | 1 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | 1 | — | — | — | — | 1 |
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 | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL3833373 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB11945 |
| UNII ID | KXG2PJ551I (ChemIDplus, GSRS) |
Target
Agency Approved
CD274
CD274
Alternate
No data
Variants
No data
Financial
No data
Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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3,638 adverse events reported
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