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Drug ReportsTisotumab vedotin
Tisotumab vedotin
Tivdak (tisotumab vedotin) is an antibody drug conjugate pharmaceutical. Tisotumab vedotin was first approved as Tivdak on 2021-09-20. The pharmaceutical is active against tissue factor.
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FDA approval date
EMA approval date
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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
Tivdak
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)
Tisotumab vedotin
Tradename
Proper name
Company
Number
Date
Products
Tivdaktisotumab vedotin-tftvSeagenN-761208 RX2021-09-20
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
tivdakBiologic Licensing Application2024-10-25
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01F: Monoclonal antibodies and antibody drug conjugates
— L01FX: Other monoclonal antibodies and antibody drug conjugates in atc
— L01FX23: Tisotumab vedotin
HCPCS
Code
Description
J9273
Injection, tisotumab vedotin-tftv, 1 mg
Clinical
Clinical Trials
12 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
Uterine cervical neoplasmsD002583HP_0030159—352——7
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Ovarian neoplasmsD010051EFO_0003893C5624———4
Non-small-cell lung carcinomaD002289——24———4
Squamous cell carcinoma of head and neckD000077195——13———3
Prostatic neoplasmsD011471—C6123———3
Endometrial neoplasmsD016889EFO_0004230—23———3
Esophageal neoplasmsD004938—C1523———3
Urinary bladder neoplasmsD001749—C6723———3
NeoplasmsD009369—C8021———2
Squamous cell carcinomaD002294——12———2
Fallopian tube neoplasmsD005185———1———1
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Indications Phases 1
No data
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
SepsisD018805HP_0100806A41.9————11
AgranulocytosisD000380HP_0012234D70————11
ToxemiaD014115——————11
Opportunistic infectionsD009894——————11
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameTisotumab vedotin
INNtisotumab vedotin
Description
Tisotumab vedotin, sold under the brand name Tivdak, is an antibody-drug conjugate used to treat cervical cancer. It is a combination of tisotumab, a monoclonal antibody against tissue factor, and monomethyl auristatin E (MMAE), a potent inhibitor of cell division. It is administered by infusion into a vein.
Classification
Antibody
Drug classsynthetic analogs of the dolastatin series; monoclonal antibodies
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Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID1418731-10-8
RxCUI—
ChEMBL IDCHEMBL4297841
ChEBI ID—
PubChem CID—
DrugBankDB16732
UNII IDT41737F88A (ChemIDplus, GSRS)
Target
Agency Approved
F3
F3
Organism
Homo sapiens
Gene name
F3
Gene synonyms
NCBI Gene ID
Protein name
tissue factor
Protein synonyms
CD142, Coagulation factor III, coagulation factor III (thromboplastin, tissue factor), Thromboplastin
Uniprot ID
Mouse ortholog
F3 (14066)
tissue factor (P20352)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Tivdak – Seagen
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Tivdak – Pfizer
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Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 398 documents
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Safety
Black-box Warning
Black-box warning for: Tivdak
Adverse Events
Top Adverse Reactions
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438 adverse events reported
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