Product Description
Venetoclax is used alone or in combination with obinutuzumab (Gazyva) or rituximab (Rituxan) to treat certain types of chronic lymphocytic leukemia (CLL; a type of cancer that begins in the white blood cells) or certain types of small lymphocytic lymphoma (SLL; a type of cancer that begins mostly in the lymph nodes). It is also used in combination with either azacitidine (Vidaza), decitabine (Dacogen), or cytarabine as a first treatment for acute myeloid leukemia (AML; a type of cancer that begins in the white blood cells) in people 75 years of age or older, or in adults who have medical conditions that prevents them from being treated with other chemotherapy medications. Venetoclax is in a class of medications called B-cell lymphoma-2 (BCL-2) inhibitors. It works by blocking the action of a certain protein in the body that helps cancer cells survive. This helps to kill cancer cells. (Sourced from: https://medlineplus.gov/druginfo/meds/a616028.html)
Mechanisms of Action: BCL2 Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: Breakthrough Therapy - Myelodysplastic Syndrome *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | Ireland | Israel | Italy | Japan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Netherlands | New Zealand | Norway | Peru | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sweden | Switzerland | Taiwan | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay
Approved Indications: Acute Leukemia | Acute Lymphoid Leukemia | Acute Myeloid Leukemia | Chronic Leukemia | Chronic Lymphoid Leukemia | Chronic Myeloid Leukemia | Leukemia | Lymphoid Leukemia | Lymphoma | Myeloid Leukemia
Known Adverse Events: Hypotension | Abdominal Pain | Dizziness | Pain Unspecified | Anemia | Febrile Neutropenia | Thrombocytopenia | Neutropenia | Respiratory Tract Infections | Sepsis | Musculoskeletal Pain | Acute Myeloid Leukemia | Chronic Lymphoid Leukemia | Pneumonia | Dyspnea | Constipation | Diarrhea | Edema
Company: AbbVie
Company Location: NORTH CHICAGO IL 60064
Company CEO: Richard A. Gonzalez
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Israel, Italy, Japan, Korea, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Puerto Rico, Romania, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 252
Highest Development Phases
Phase 3: Acute Lymphoid Leukemia|Acute Myeloid Leukemia|Allogeneic Stem Cell Transplant|Chronic Lymphoid Leukemia|Chronic Myeloid Leukemia|Leukemia|Lymphocytic Chronic B-Cell Leukemia|Lymphoma|Lymphoma, B-Cell|Lymphoma, Non-Hodgkin|Mantle-Cell Lymphoma|Multiple Myeloma|Myelodysplastic Syndrome|Precursor B-Cell Lymphoblastic Leukemia-Lymphoma|Precursor Cell Lymphoblastic Leukemia-Lymphoma|Preleukemia|Prolymphocytic Leukemia|Waldenstrom Macroglobulinemia
Phase 2: Acquired Immunodeficiency Syndrome|Acute Monocytic Leukemia|Acute Myelomonocytic Leukemia|Amyloidosis|B-Cell Marginal Zone Lymphoma|Chronic Myelomonocytic Leukemia|Diffuse Large B-Cell Lymphoma|Follicular Lymphoma|HIV Infections|Juvenile Myelomonocytic Leukemia,|Myelogenous, Chronic, BCR-ABL Positive Leukemia|Oncology Unspecified|Precursor T-Cell Lymphoblastic Leukemia-Lymphoma|T-Cell Leukemia|T-Cell Peripheral Lymphoma|Tic Disorders
Phase 1: B-Cell Leukemia|Biphenotypic Acute Leukemia|Bone Cancer|Burkitt Lymphoma|Healthy Volunteers|Kidney Diseases|Leukemia, Plasma Cell|Myelofibrosis|Myeloproliferative Disorders|Neuroblastoma|Prostate Cancer|Sarcoma, Myeloid|Soft Tissue Cancer
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| 2018-001475-20 | P2 |
Active, not recruiting |
Chronic Lymphoid Leukemia |
2047-01-21 |
|
| AMLSG 31-19 / HOVON 501 / AbbVie B18-982 | P3 |
Active, not recruiting |
Myelodysplastic Syndrome |
2034-12-15 |
|
| MK-1026-010 | P3 |
Unknown Status |
Chronic Lymphoid Leukemia|Lymphoma |
2033-06-27 |
|
| BELLWAVE-010 | P3 |
Recruiting |
Lymphocytic Chronic B-Cell Leukemia|Chronic Lymphoid Leukemia|Lymphoma, B-Cell |
2033-06-27 |