Trodelvy(sacituzumab govitecan)
Trodelvy (sacituzumab govitecan) is an antibody 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
Commercial
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 |
|---|---|---|---|---|---|
| Trodelvy | sacituzumab govitecan-hziy | Gilead Sciences | N-761115 RX | 2020-04-22 | 1 products |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| trodelvy | Biologic Licensing Application | 2020-04-28 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| triple negative breast neoplasms | — | D064726 | — |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J9317 | Injection, sacituzumab govitecan-hziy, 2.5 mg |
Clinical
Clinical Trials
60 clinical trials
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Triple negative breast neoplasms | D064726 | 5 | 16 | 5 | — | 1 | 22 | ||
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 3 | 12 | 4 | — | — | 17 |
| Non-small-cell lung carcinoma | D002289 | 2 | 4 | 2 | — | — | 6 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Urologic neoplasms | D014571 | C64-C68 | 4 | 4 | — | — | — | 5 | |
| Urinary bladder neoplasms | D001749 | C67 | 3 | 3 | — | — | — | 4 | |
| Invasive hydatidiform mole | D002820 | D39.2 | — | 3 | — | — | — | 3 | |
| Glioblastoma | D005909 | EFO_0000515 | 2 | 2 | — | — | — | 3 | |
| Endometrial neoplasms | D016889 | EFO_0004230 | 1 | 2 | — | — | — | 2 | |
| Residual neoplasm | D018365 | — | 1 | — | — | — | 1 | ||
| Prostatic neoplasms | D011471 | C61 | — | 1 | — | — | — | 1 | |
| Renal cell carcinoma | D002292 | 1 | 1 | — | — | — | 1 | ||
| Castration-resistant prostatic neoplasms | D064129 | 1 | 1 | — | — | — | 1 | ||
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 1 | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Liver failure | D017093 | HP_0001399 | K72.9 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | SACITUZUMAB GOVITECAN |
| INN | sacituzumab 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 class | monoclonal antibodies; antineoplastics (camptothecin derivatives) |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 1491917-83-9 |
| RxCUI | — |
| ChEMBL ID | CHEMBL3545262 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB12893 |
| UNII ID | M9BYU8XDQ6 (ChemIDplus, GSRS) |
Target
Agency Approved
TACSTD2
TACSTD2
Organism
Homo sapiens
Gene name
TACSTD2
Gene synonyms
GA733-1, M1S1, TROP2
NCBI Gene ID
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
Mouse ortholog
Tacstd2 (56753)
tumor-associated calcium signal transducer 2 (Q8BGV3)
Alternate
No data
Variants
Clinical Variant
No data
Financial
Trodelvy - Gilead Sciences
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 1,073 documents
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Safety
Black-box Warning
Black-box warning for: Trodelvy
Adverse Events
Top Adverse Reactions
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357 adverse events reported
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