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Title | Trodelvy (sacituzumab govitecan-hziy) FDA Drug Label | ||||||||||||
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URL | https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761115 | ||||||||||||
Abstract Text |
Molecular Profile | Treatment Approach |
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Gene Name | Source | Synonyms | Protein Domains | Gene Description | Gene Role |
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Therapy Name | Drugs | Efficacy Evidence | Clinical Trials |
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Sacituzumab govitecan-hziy | Sacituzumab govitecan-hziy | 0 | 34 |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
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Sacituzumab govitecan-hziy | Trodelvy | IMMU-132|Sactizumab|Sacituzumab govitecan | TROP2 Antibody 7 | Trodelvy (sacituzumab govitecan-hziy) is an antibody-drug conjugate composed of a monoclonal anti-TROP2 antibody linked to the active metabolite of irinotecan (SN-38), which binds to TROP2 positive cancer cells and induces DNA breakage and apoptosis (PMID: 26541586). Trodelvy (sacituzumab govitecan-hziy) is FDA approved for use in patients with metastatic triple-negative breast cancer who received two or more prior therapies, in patients with hormone receptor-positive, ERBB2 (HER2)-negative breast cancer who have received endocrine-based therapy and at least two additional systemic therapies, and in patients with locally advanced or metastatic urothelial cancer who received a platinum-containing chemotherapy and a PD-1 or PD-L1 inhibitor (FDA.gov). |
Gene | Variant | Impact | Protein Effect | Variant Description | Associated with drug Resistance |
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Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
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