Product Description
BAVENCIO® (avelumab) is indicated for the maintenance treatment of patients with locally advanced or metastatic urothelial carcinoma (UC) that has not progressed with first-line platinum-containing chemotherapy. (Sourced from: https://www.bavencio.com/hcp)
Mechanisms of Action: PD-L1 Inhibitor
Novel Mechanism: No
Modality: Antibody
Route of Administration: Intravenous
FDA Designation: Breakthrough Therapy - Transitional Cell Carcinoma *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Belgium | Brazil | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | Ireland | Israel | Italy | Japan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Mexico | Netherlands | Norway | Peru | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | Spain | Sweden | Switzerland | Taiwan | Turkey | United Arab Emirates | United Kingdom | United States
Approved Indications: None
Known Adverse Events: None
Company: Pfizer
Company Location: NEW YORK NY 10017
Company CEO: Albert Bourla
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belgium, Bosnia, Brazil, Bulgaria, Canada, Chile, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Lebanon, Lithuania, Mexico, Netherlands, New Zealand, Peru, Poland, Portugal, Romania, Russia, Serbia, Singapore, Slovakia, Spain, Sweden, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 2
Highest Development Phases
Phase 3: Bladder Cancer|Breast Cancer|Carcinoma, Merkel Cell|Colorectal Cancer|Head and Neck Cancer|Hepatocellular Carcinoma|Lung Cancer|Melanoma|Non-Small-Cell Lung Cancer|Oncology Solid Tumor Unspecified|Oncology Unspecified|Ovarian Cancer|Renal Cell Carcinoma|Small Cell Lung Cancer|Squamous Cell Carcinoma|Transitional Cell Carcinoma|Triple Negative Breast Cancer
Phase 2: Adenocarcinoma|Anal Cancer|Anus Cancer|Anus Diseases|Biliary Tract Cancer|Cervical Cancer|Cutaneous Squamous Cell Carcinoma|Endometrial Cancer|Esophageal Cancer|Gastrointestinal Cancer|Gestational Trophoblastic Disease|Glioblastoma|Hodgkin Lymphoma|Kidney Cancer|Lymphoma|Mesothelioma|Neuroendocrine Carcinoma|Neuroendocrine Tumors|Oropharyngeal Cancer|Other|Pancreatic Cancer|Penile Cancer|Pleural Cancer|Prostate Cancer|Sarcoma|Soft Tissue Cancer|Thymoma|Thyroid Cancer|Uterine Cancer|Vaginal Cancer|Vaginal Diseases|Vulvar Cancer
Phase 1: Autoimmune Disease Unspecified|Healthy Volunteers|Lymphoma, B-Cell|Lymphoma, Non-Hodgkin|Psoriasis
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| QUILT-3.055 | P2 |
Recruiting |
Non-Small-Cell Lung Cancer|Transitional Cell Carcinoma|Squamous Cell Carcinoma|Carcinoma, Merkel Cell|Gastrointestinal Cancer|Uterine Cancer|Renal Cell Carcinoma|Hepatocellular Carcinoma|Cervical Cancer|Colorectal Cancer|Melanoma|Head and Neck Cancer |
2029-08-31 |
|
| SGIP21027 | P2 |
Recruiting |
Pancreatic Cancer|Adenocarcinoma |
2028-12-31 |
57% |
| SGIP21027 | P2 |
Recruiting |
Pancreatic Cancer|Adenocarcinoma |
2028-12-31 |
57% |
| ONCA-016-21F | P2 |
Not yet recruiting |
Bladder Cancer|Transitional Cell Carcinoma |
2028-12-31 |
|
| SAMURAI | P2 |
Recruiting |
Renal Cell Carcinoma |
2028-06-15 |