Product Description
Bendamustine injection is used to treat chronic lymphocytic leukemia (CLL; a type of cancer of the white blood cells). Bendamustine injection is also used to treat a type of non-Hodgkins lymphoma (NHL: cancer that begins in a type of white blood cell that normally fights infection) that is slow spreading, but has continued to worsen during or after treatment with another medication. Bendamustine is in a class of medications called alkylating agents. It works by killing existing cancer cells and limiting the growth of new cancer cells. (Sourced from: https://medlineplus.gov/druginfo/meds/a608034.html)
Mechanisms of Action: CD20 Antagonist
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Intravenous
FDA Designation: None *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Bulgaria | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Netherlands | New Zealand | Norway | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: Chronic Leukemia | Chronic Lymphoid Leukemia | Leukemia | Lymphoid Leukemia | B-Cell Leukemia | Chronic Leukemia | Chronic Lymphoid Leukemia | Hodgkin Lymphoma | Leukemia | Lymphocytic Chronic B-Cell Leukemia | Lymphoid Leukemia | Lymphoma | Lymphoma, B-Cell | Lymphoma, Non-Hodgkin
Known Adverse Events: Anemia | Leukopenia | Thrombocytopenia | Neutropenia | Headache | Stomatitis | Lymphopenia | Chronic Lymphoid Leukemia | Dyspnea | Anorexia | Constipation | Diarrhea
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, Canada, China, Croatia, Czech Republic, Finland, France, Germany, Greece, Hungary, Israel, Italy, Japan, Korea, New Zealand, Poland, Portugal, Puerto Rico, Romania, Russia, Serbia, Singapore, South Korea, Spain, Sweden, Taiwan, Turkey, Ukraine, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 43
Highest Development Phases
Phase 3: Chronic Lymphoid Leukemia|Diffuse Large B-Cell Lymphoma|Hodgkin Lymphoma|Lymphoma|Lymphoma, Non-Hodgkin
Phase 2: Acute Respiratory Distress Syndrome|Follicular Lymphoma|Lung Cancer|Lymphocytic Chronic B-Cell Leukemia|Lymphoma, B-Cell|Mantle-Cell Lymphoma|Mesothelioma|Pleural Cancer|T-Cell Peripheral Lymphoma|Waldenstrom Macroglobulinemia
Phase 1: Neuroendocrine Carcinoma|Prostate Cancer|Psoriasis|Small Cell Carcinoma
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| REFRACT | P2 |
Recruiting |
Follicular Lymphoma |
2029-05-31 |
|
| RG1123589 | P1 |
Not yet recruiting |
Neuroendocrine Carcinoma|Prostate Cancer|Small Cell Carcinoma |
2028-03-15 |
|
| HM-225 | P2 |
Not yet recruiting |
Lymphoma, Non-Hodgkin |
2027-09-29 |
|
| ACE-LY-308 | P3 |
Unknown Status |
Lymphoma |
2027-05-15 |