Product Description
Trastuzumab emtansine (T-DM1) is an antibody-drug conjugate incorporating the human epidermal growth factor receptor 2 (HER2)-targeted antitumor properties of trastuzumab with the cytotoxic activity of the microtubule-inhibitory agent DM1. The antibody and the cytotoxic agent are conjugated by means of a stable linker. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/23020162/)
Mechanisms of Action: ERBB2 Inhibitor
Novel Mechanism: No
Modality: Antibody Drug Conjugate
Route of Administration: Intravenous
FDA Designation: None *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Belgium | Bosnia | Brazil | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Mexico | Netherlands | New Zealand | Norway | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sweden | Switzerland | Taiwan | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: Breast Cancer | Oncology Solid Tumor Unspecified | Oncology Unspecified
Known Adverse Events: Labor Pain | Pain Unspecified | Thrombocytopenia | Drug Hypersensitivity | Musculoskeletal Pain | Constipation
Company: Hoffmann-La Roche
Company Location: BASEL SWITZERLAND V8
Company CEO: Severin Schwan
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, Iceland, India, Ireland, Italy, Kenya, Korea, Mexico, Netherlands, New Zealand, Norway, Panama, Peru, Poland, Portugal, Romania, Russia, Singapore, Slovakia, Slovenia, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, United States, Unknown Location, Venezuela, Vietnam
Active Clinical Trial Count: 23
Highest Development Phases
Phase 3: Breast Cancer
Phase 2: Adenocarcinoma|Bladder Cancer|Brain Cancer|Esophageal Cancer|Gastrointestinal Cancer|Lung Cancer|Oncology Solid Tumor Unspecified|Salivary Gland Cancer|Urologic Cancer
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| WO42633 | P3 |
Unknown Status |
Breast Cancer |
2035-06-29 |
|
| 2020-003681-40 | P3 |
Active, not recruiting |
Breast Cancer |
2035-03-01 |
|
| 2020-003205-66 | P2 |
Active, not recruiting |
Breast Cancer |
2030-03-17 |
|
| MEDOPP293 | P2 |
Unknown Status |
Breast Cancer |
2030-01-31 |