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Sacituzumab govitecan

Alternative Names: sacituzumab govitecan, immu-132, trodelvy, sacituzumab govitecan-hziy
Latest Update: 2024-10-12
Latest Update Note: Clinical Trial Update

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 Cancer
Accelerated Approval - Oncology Solid Tumor Unspecified|Transitional Cell Carcinoma
Fast Track - Oncology Solid Tumor Unspecified|Transitional Cell Carcinoma
Orphan Drug - Breast Cancer|Oncology Solid Tumor Unspecified|Triple Negative Breast Cancer
Orphan 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

Map of Global Clinical Trials for Sacituzumab govitecan

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:

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|Alopecia|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

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

Not yet recruiting

Triple Negative Breast Cancer

2029-09-01

NCT06477419

P2

Recruiting

Mesothelioma

2029-06-21

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