Product Description
Acalabrutinib is used to treat mantle cell lymphoma (MCL) in adults who have received at least one previous treatment for their cancer. This medicine is also used to treat chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).This medicine is available only with your doctor's prescription. (Sourced from: https://www.mayoclinic.org/drugs-supplements/acalabrutinib-oral-route/side-effects/drg-20406641?p=1)
Mechanisms of Action: Btk Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: Accelerated Approval - Mantle-Cell LymphomaPriority Review - Lymphoma *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Bangladesh | Belgium | Brazil | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lithuania | Luxembourg | Malaysia | Netherlands | New Zealand | Norway | Peru | 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 | Vietnam
Approved Indications: Lymphoma | Chronic Leukemia | Chronic Lymphoid Leukemia | Leukemia | Lymphoid Leukemia | Lymphoma
Known Adverse Events: Headache | Anemia | Thrombocytopenia | Neutropenia | Myalgia | Diarrhea | Pain Unspecified | Respiratory Tract Infections | Musculoskeletal Pain
Company: AstraZeneca
Company Location: CAMBRIDGE X0 CB2 0AA
Company CEO: Pascal Soriot
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Israel, Italy, Japan, Korea, Lithuania, Mexico, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States, Unknown Location, Vietnam
Active Clinical Trial Count: 78
Highest Development Phases
Phase 3: Chronic Lymphoid Leukemia|Diffuse Large B-Cell Lymphoma|Leukemia|Lymphocytic Chronic B-Cell Leukemia|Lymphoma|Lymphoma, B-Cell|Mantle-Cell Lymphoma
Phase 2: Anaphylaxis|Bone Cancer|Bronchiolitis Obliterans|Cross Infection|Environmental Hypersensitivity|Evans Syndrome|Follicular Lymphoma|Food Hypersensitivity|Graft vs Host Disease|Heart Block|Heart Cancer|Heart Transplant|Hypertension|Lymphoma, Non-Hodgkin|Lymphoproliferative Disorders|Marginal Zone Lymphoma|Mental Fatigue|Nose Cancer|Peanut Hypersensitivity|Peripheral Nervous System Diseases|Pregnancy Outcomes|Primary Central Nervous System Lymphoma|Prolymphocytic Leukemia|Stem Cell Transplant|Stroke|Waldenstrom Macroglobulinemia
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| 2019-004337-17 | P2 |
Active, not recruiting |
Chronic Lymphoid Leukemia |
2032-07-23 |
|
| SAKK 38/19 | P2 |
Active, not recruiting |
Lymphoma, B-Cell |
2032-04-29 |
|
| ALTAMIRA | P2 |
Active, not recruiting |
Lymphoma |
2032-04-07 |
|
| 17-BI-1206-02 | P2 |
Unknown Status |
Lymphoma, Non-Hodgkin|Lymphoma, B-Cell |
2031-05-21 |