Product Description
Trastuzumab deruxtecan (DS-8201) is an antibody-drug conjugate composed of an anti-HER2 (human epidermal growth factor receptor 2) antibody, a cleavable tetrapeptide-based linker, and a cytotoxic topoisomerase I inhibitor.
Mechanisms of Action: ERBB2 Inhibitor,TOP2 Inhibitor
Novel Mechanism: No
Modality: Antibody Drug Conjugate
Route of Administration: Intravenous
FDA Designation: Priority Review - Breast Cancer *
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 | Japan | Korea | Latvia | Lithuania | Luxembourg | Mexico | Netherlands | Norway | Poland | Portugal | Romania | Russia | Saudi Arabia | Singapore | Slovakia | Slovenia | Spain | Sweden | Switzerland | Taiwan | United Arab Emirates | United Kingdom | United States | Uruguay
Approved Indications: Adenocarcinoma | Breast Cancer | Esophageal Cancer | Gastrointestinal Cancer | Lung Cancer | Non-Small-Cell Lung Cancer | Oncology Solid Tumor Unspecified | Small Cell Carcinoma | Small Cell Lung Cancer | Oncology Unspecified
Known Adverse Events: Labor Pain | Pain Unspecified | Alopecia | Musculoskeletal Pain | Hypokalemia | Breast Cancer | Gastrointestinal Cancer | Non-Small-Cell Lung Cancer | Oncology Solid Tumor Unspecified | Oncology Unspecified | Constipation | Diarrhea
Company: AstraZeneca
Company Location: CAMBRIDGE X0 CB2 0AA
Company CEO: Pascal Soriot
Additonal Commercial Interests: Daiichi Sankyo
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 1
Highest Development Phases
Phase 3: Adenocarcinoma|Biliary Tract Cancer|Brain Cancer|Breast Cancer|Esophageal Cancer|Gastrointestinal Cancer|Inflammatory Breast Cancer|Non-Small-Cell Lung Cancer|Oncology Solid Tumor Unspecified|Small Cell Lung Cancer
Phase 2: Bladder Cancer|Cervical Cancer|Colorectal Cancer|Endometrial Cancer|Glioblastoma|Melanoma|Meningeal Cancer|Meningeal Carcinomatosis|Nose Cancer|Oncology Unspecified|Ovarian Cancer|Pancreatic Cancer|Prostate Cancer|Spinal Cord Cancer
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| NCI-2022-09968 | P1 |
Recruiting |
Breast Cancer |
2030-12-31 |
|
| jRCT2061200033 | P3 |
Recruiting |
Breast Cancer |
2030-12-31 |
|
| D967UC00001 | P3 |
Unknown Status |
Breast Cancer |
2029-12-30 |
|
| WSG-AM12 | P2 |
Unknown Status |
Breast Cancer |
2029-09-30 |