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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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| skin and connective tissue diseases | D017437 |
Trade Name
FDA
EMA
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Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
No data
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| trodelvy | Biologic Licensing Application | 2024-09-03 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J9317 | Injection, sacituzumab govitecan-hziy, 2.5 mg |
Clinical
Clinical Trials
112 clinical trials
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 12 | 32 | 9 | — | 5 | 50 |
| Triple negative breast neoplasms | D064726 | — | — | 7 | 22 | 6 | — | 2 | 32 |
| Carcinoma | D002277 | — | C80.0 | 6 | 16 | 2 | — | — | 21 |
| Urinary bladder neoplasms | D001749 | — | C67 | 4 | 8 | 1 | — | 1 | 12 |
| Non-small-cell lung carcinoma | D002289 | — | — | 3 | 8 | 2 | — | — | 11 |
| Urologic neoplasms | D014571 | — | C64-C68 | 4 | 6 | 2 | — | — | 9 |
| Transitional cell carcinoma | D002295 | — | — | 3 | 5 | 2 | — | — | 8 |
| Lung neoplasms | D008175 | HP_0100526 | C34.90 | 2 | 5 | 1 | — | — | 7 |
| Endometrial neoplasms | D016889 | EFO_0004230 | — | 2 | 3 | 1 | — | — | 4 |
| Ureteral neoplasms | D014516 | EFO_0003844 | C66 | 1 | — | 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 mole | D002820 | — | D39.2 | 1 | 4 | — | — | — | 5 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 2 | 4 | — | — | — | 5 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 1 | 5 | — | — | — | 5 |
| Recurrence | D012008 | — | — | — | 3 | — | — | — | 3 |
| Glioblastoma | D005909 | EFO_0000515 | — | 2 | 2 | — | — | — | 3 |
| Small cell lung carcinoma | D055752 | — | — | 2 | 3 | — | — | — | 3 |
| Adenocarcinoma | D000230 | — | — | 2 | 3 | — | — | — | 3 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 2 | 3 | — | — | — | 3 |
| Neuroendocrine carcinoma | D018278 | — | — | 1 | 3 | — | — | — | 3 |
| Squamous cell carcinoma | D002294 | — | — | — | 3 | — | — | — | 3 |
Show 36 more
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 |
| Gastrointestinal neoplasms | D005770 | — | C26.9 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sepsis | D018805 | HP_0100806 | A41.9 | — | — | — | — | 1 | 1 |
| Agranulocytosis | D000380 | HP_0012234 | D70 | — | — | — | — | 1 | 1 |
| Toxemia | D014115 | — | — | — | — | — | — | 1 | 1 |
| Opportunistic infections | D009894 | — | — | — | — | — | — | 1 | 1 |
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 | — |
| 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
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Variants
No data
Financial
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Trodelvy – Gilead Sciences
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Trends
PubMed Central
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Additional graphs summarizing 1,938 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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