Product Description
Sacituzumab govitecan is an antibody drug conjugate composed of an antibody targeting the human trophoblast cell-surface antigen 2 (Trop-2), which is expressed in the majority of breast cancers, coupled to SN-38 (topoisomerase I inhibitor) through a proprietary hydrolyzable linker.
Mechanisms of Action: TOP1 Inhibitor,TROP2 Antagonist
Novel Mechanism: No
Modality: Antibody Drug Conjugate
Route of Administration: Intravenous
FDA Designation: Accelerated Approval - Breast Cancer|Oncology Solid Tumor Unspecified|Triple Negative Breast CancerAccelerated Approval - Oncology Solid Tumor Unspecified|Transitional Cell CarcinomaFast Track - Oncology Solid Tumor Unspecified|Transitional Cell CarcinomaOrphan Drug - Breast Cancer|Oncology Solid Tumor Unspecified|Triple Negative Breast CancerOrphan Drug - Glioblastoma *
Approval Status: Approved
Approved Countries: Australia | Austria | Belgium | Brazil | Canada | Croatia | Czech | Denmark | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | Ireland | Israel | Italy | Latvia | Lithuania | Luxembourg | Netherlands | Norway | Poland | Portugal | Romania | Saudi Arabia | Singapore | Slovakia | Slovenia | Spain | Sweden | Switzerland | Taiwan | Turkey | United Arab Emirates | United Kingdom | United States
Approved Indications: None
Known Adverse Events: None
Company: Gilead Sciences
Company Location: FOSTER CITY CA 94404
Company CEO: Daniel P. O’Day
Additonal Commercial Interests: Everest Medicines
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Croatia, Czech Republic, France, Georgia, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, Poland, Portugal, Puerto Rico, Romania, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States
Active Clinical Trial Count: 87
Highest Development Phases
Phase 3: Breast Cancer|Endometrial Cancer|Non-Small-Cell Lung Cancer|Oncology Solid Tumor Unspecified|Transitional Cell Carcinoma|Triple Negative Breast Cancer
Phase 2: Adenocarcinoma|Anaplastic Thyroid Carcinoma|Bladder Cancer|Brain Cancer|Cervical Cancer|Esophageal Cancer|Gastrointestinal Cancer|Male Breast Cancer|Mesothelioma|Muscle Cancer|Ovarian Cancer|Prostate Cancer|Salivary Gland Cancer|Small Cell Lung Cancer|Squamous Cell Carcinoma|Thymoma|Thyroid Cancer|Uterine Cancer
Phase 1: Glioblastoma|Kidney Cancer|Liver Failure|Renal Cell Carcinoma|Ureteral Cancer
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| GS-US-595-6184 | P3 |
Unknown Status |
Triple Negative Breast Cancer |
2033-05-20 |
|
| WSG-AM13 | P2 |
Unknown Status |
Triple Negative Breast Cancer |
2030-06-30 |
|
| TROPHY U-01 | P2 |
Recruiting |
Transitional Cell Carcinoma |
2030-06-01 |
|
| ADAPT-TN-III | P2 |
Recruiting |
Triple Negative Breast Cancer |
2029-09-01 |