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Drug ReportsAvelumab
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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Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
neoplasmsD009369
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
BavencioavelumabEMD SeronoN-761049 RX2017-03-23
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
bavencioBiologic Licensing Application2024-11-05
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
transitional cell carcinoma—D002295—
merkel cell carcinomaEFO_1001471D015266C4A
Agency Specific
FDA
EMA
Expiration
Code
avelumab, Bavencio, EMD Serono, Inc.
2024-03-23Orphan excl.
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01F: Monoclonal antibodies and antibody drug conjugates
— L01FF: Pd-1/pdl-1 (programmed cell death protein 1/death ligand 1) inhibitors
— L01FF04: Avelumab
HCPCS
Code
Description
J9023
Injection, avelumab, 10 mg
Clinical
Clinical Trials
289 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
CarcinomaD002277—C80.025596—1086
NeoplasmsD009369—C8034242—654
Transitional cell carcinomaD002295——6172—528
Urologic neoplasmsD014571—C64-C688171—527
Renal cell carcinomaD002292EFO_0000376—6133—827
Non-small-cell lung carcinomaD002289——17183——27
Breast neoplasmsD001943EFO_0003869C509141——20
Urinary bladder neoplasmsD001749—C675171—220
Merkel cell carcinomaD015266EFO_1001471C4A8151—119
Squamous cell carcinomaD002294——7121——16
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Colorectal neoplasmsD015179——617———19
Pancreatic neoplasmsD010190EFO_0003860C2599———11
Neoplasm metastasisD009362EFO_0009708—85——110
RecurrenceD012008——27———9
MelanomaD008545——64——19
Liver neoplasmsD008113EFO_1001513C22.047———8
Hepatocellular carcinomaD006528—C22.036———7
Prostatic neoplasmsD011471—C6145———6
SarcomaD012509——63———6
Squamous cell neoplasmsD018307——35———6
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Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
MycosesD009181—B35-B492————2
Mycosis fungoidesD009182—C84.02————2
FibrosarcomaD005354——1————1
Malignant fibrous histiocytomaD051677——1————1
Sezary syndromeD012751—C84.11————1
Large-cell lymphoma anaplasticD017728—C84.61————1
GliomaD005910EFO_0000520—1————1
OncogenesD009857——1————1
Meningeal neoplasmsD008577EFO_0003851C701————1
Follicular lymphomaD008224—C821————1
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Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
MyocarditisD009205—I51.4————33
Heart diseasesD006331EFO_0003777I51.9————22
Autoimmune diseasesD001327HP_0002960M30-M36————22
Cardiovascular diseasesD002318HP_0001626—————11
CardiomyopathiesD009202EFO_0000318I42————11
PericarditisD010493EFO_0007427I30————11
VasculitisD014657HP_0002633—————11
MyositisD009220EFO_0000783G72.49————11
Drug-related side effects and adverse reactionsD064420—T88.7————11
ArthritisD001168HP_0001369M05-M14————11
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameAvelumab
INNavelumab
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 classmonoclonal antibodies
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB5GRJ
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL3833373
ChEBI ID—
PubChem CID—
DrugBankDB11945
UNII IDKXG2PJ551I (ChemIDplus, GSRS)
Target
Agency Approved
CD274
CD274
Organism
Homo sapiens
Gene name
CD274
Gene synonyms
B7H1, PDCD1L1, PDCD1LG1, PDL1
NCBI Gene ID
29126
Protein name
programmed cell death 1 ligand 1
Protein synonyms
B7 homolog 1, B7-H1, CD274, CD274 antigen, PDCD1 ligand 1
Uniprot ID
Q9NZQ7
Mouse ortholog
Cd274 (60533)
programmed cell death 1 ligand 1 (Q9EP73)
Alternate
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 12,243 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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3,086 adverse events reported
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