Product Description
Trastuzumab, a recombinant antibody targeting HER2, was the first biological drug approved for the treatment of HER2-positive BC. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/26892619/)
Mechanisms of Action: ERBB2 Inhibitor
Novel Mechanism: No
Modality: Antibody
Route of Administration: Intravenous
FDA Designation: None *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Canada | Chile | China | 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 | Morocco | Netherlands | New Zealand | Norway | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: None
Known Adverse Events: None
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, Bangladesh, Belgium, Bosnia, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Korea, Latvia, Lebanon, Malaysia, Mexico, Netherlands, New Zealand, Norway, Oman, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Uganda, Ukraine, United Arab Emirates, United Kingdom, United States, Unknown Location, Vietnam
Active Clinical Trial Count: 151
Highest Development Phases
Phase 3: Adenocarcinoma|Biliary Tract Cancer|Breast Cancer|Colorectal Cancer|Esophageal Cancer|Gastrointestinal Cancer|Inflammatory Breast Cancer|Lymphoproliferative Disorders|Oncology Solid Tumor Unspecified|Pancreatic Cancer|Prostate Cancer|Unilateral Breast Cancer
Phase 2: Abnormalities, Multiple|Bladder Cancer|Brain Cancer|Brain Stem Cancer|Central Nervous System Cancer|Cervical Cancer|Cholangiocarcinoma|Hodgkin Lymphoma|Intestinal Cancer|Lymphoma, B-Cell|Lymphoma, Non-Hodgkin|Male Breast Cancer|Meningeal Cancer|Meningeal Carcinomatosis|Multiple Myeloma|Non-Small-Cell Lung Cancer|Oncology Unspecified|Spinal Cord Cancer|Vision, Low
Phase 1: Breast Diseases|Healthy Volunteers
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| 2020-003205-66 | P2 |
Active, not recruiting |
Breast Cancer |
2030-03-17 |
|
| EPIK-B2 | P3 |
Active, not recruiting |
Breast Cancer |
2030-02-07 |
|
| jRCT2041240173 | P3 |
Not yet recruiting |
Esophageal Cancer|Gastrointestinal Cancer |
2030-02-01 |
|
| MEDOPP293 | P2 |
Unknown Status |
Breast Cancer |
2030-01-31 |