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Drug ReportsSacituzumab govitecan
Trodelvy(sacituzumab govitecan)
Trodelvy (sacituzumab govitecan) is an antibody drug conjugate pharmaceutical. Sacituzumab govitecan was first approved as Trodelvy on 2020-04-22. It is used to treat triple negative breast neoplasms in the USA. It has been approved in Europe to treat breast neoplasms and triple negative breast neoplasms. The pharmaceutical is active against tumor-associated calcium signal transducer 2.
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FDA Novel Drug Approvals 2020
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
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
neoplasmsD009369
skin and connective tissue diseasesD017437
Trade Name
FDA
EMA
Trodelvy
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)
Sacituzumab govitecan
Tradename
Proper name
Company
Number
Date
Products
Trodelvysacituzumab govitecan-hziyGilead SciencesN-761115 RX2020-04-22
1 products
Labels
FDA
EMA
Brand Name
Status
Last Update
trodelvyBiologic Licensing Application2024-09-03
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
triple negative breast neoplasms—D064726—
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
— L01FX17: Sacituzumab govitecan
HCPCS
Code
Description
J9317
Injection, sacituzumab govitecan-hziy, 2.5 mg
Clinical
Clinical Trials
111 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
NeoplasmsD009369—C801213—1120
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Breast neoplasmsD001943EFO_0003869C5012329—550
Triple negative breast neoplasmsD064726——7226—232
CarcinomaD002277—C80.06152——20
Urinary bladder neoplasmsD001749—C67481—112
Non-small-cell lung carcinomaD002289——382——11
Urologic neoplasmsD014571—C64-C68452——8
Transitional cell carcinomaD002295——342——7
Lung neoplasmsD008175HP_0100526C34.90251——7
Endometrial neoplasmsD016889EFO_0004230—231——4
Ureteral neoplasmsD014516EFO_0003844C661—1——2
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Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Invasive hydatidiform moleD002820—D39.214———5
Brain neoplasmsD001932EFO_0003833C7124———5
Neoplasm metastasisD009362EFO_0009708—15———5
GlioblastomaD005909EFO_0000515—22———3
Small cell lung carcinomaD055752——23———3
AdenocarcinomaD000230——23———3
Ovarian neoplasmsD010051EFO_0003893C5623———3
Neuroendocrine carcinomaD018278——13———3
Squamous cell carcinomaD002294———3———3
RecurrenceD012008———2———2
Show 36 more
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Liver failureD017093HP_0001399K72.91————1
Gastrointestinal neoplasmsD005770—C26.91————1
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 nameSacituzumab govitecan
INNsacituzumab govitecan
Description
Sacituzumab govitecan, sold under the brand name Trodelvy, is a Trop-2-directed antibody and topoisomerase inhibitor drug conjugate used for the treatment of metastatic triple-negative breast cancer and metastatic urothelial cancer.
Classification
Antibody
Drug classmonoclonal antibodies; antineoplastics (camptothecin derivatives)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)—
Identifiers
PDB—
CAS-ID—
RxCUI—
ChEMBL IDCHEMBL3545262
ChEBI ID—
PubChem CID—
DrugBankDB12893
UNII IDM9BYU8XDQ6 (ChemIDplus, GSRS)
Target
Agency Approved
TACSTD2
TACSTD2
Organism
Homo sapiens
Gene name
TACSTD2
Gene synonyms
GA733-1, M1S1, TROP2
NCBI Gene ID
4070
Protein name
tumor-associated calcium signal transducer 2
Protein synonyms
40kD glycoprotein, identified by monoclonal antibody GA733, Cell surface glycoprotein Trop-2, cell surface glycoprotein TROP2, epithelial glycoprotein-1, gastrointestinal tumor-associated antigen GA7331, Membrane component chromosome 1 surface marker 1, membrane component, chromosome 1, surface marker 1, Pancreatic carcinoma marker protein GA733-1, pancreatic carcinoma marker protein GA7331, trophoblast cell surface antigen 2
Uniprot ID
Q96QD2
Mouse ortholog
Tacstd2 (56753)
tumor-associated calcium signal transducer 2 (Q8BGV3)
Alternate
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Trodelvy – Gilead Sciences
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Tabular view
Estimated US medical usage
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,913 documents
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Safety
Black-box Warning
Black-box warning for: Trodelvy
Adverse Events
Top Adverse Reactions
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3,273 adverse events reported
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