New FDA Approval for CALQUENCE® (acalabrutinib)
On March 2nd, 2026
AstraZeneca has announced that the US Food and Drug Administration (FDA) has approved a new treatment regimen for CALQUENCE® (acalabrutinib) in combination with venetoclax for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Approval was based on results from the randomized, multicenter, open-label phase III AMPLIFY trial.
AMPLIFY 3.5-Year Data Leave Behind
Select Safety Information
Serious adverse events, including fatal events, have occurred with CALQUENCE, including serious and opportunistic infections, hemorrhage, cytopenias, second primary malignancies, cardiac arrhythmias, and hepatotoxicity, including drug-induced liver injury. The most common adverse reactions (≥30%) are upper respiratory tract infection, diarrhea, headache, and musculoskeletal pain. The most common Grade 3 or 4 laboratory abnormalities (≥10%) are absolute neutrophil count decreased, uric acid increased, absolute lymphocyte count decreased, and platelets decreased.
Indication and Usage
CALQUENCE is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Please see full Prescribing Information, including Patient Information. You may report side effects related to AstraZeneca products (Opens new window).
AstraZeneca has announced that the US Food and Drug Administration (FDA) has approved a new treatment regimen for CALQUENCE® (acalabrutinib) in combination with venetoclax for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Approval was based on results from the randomized, multicenter, open-label phase III AMPLIFY trial.
AMPLIFY 3.5-Year Data Leave Behind
Select Safety Information
Serious adverse events, including fatal events, have occurred with CALQUENCE, including serious and opportunistic infections, hemorrhage, cytopenias, second primary malignancies, cardiac arrhythmias, and hepatotoxicity, including drug-induced liver injury. The most common adverse reactions (≥30%) are upper respiratory tract infection, diarrhea, headache, and musculoskeletal pain. The most common Grade 3 or 4 laboratory abnormalities (≥10%) are absolute neutrophil count decreased, uric acid increased, absolute lymphocyte count decreased, and platelets decreased.
Indication and Usage
CALQUENCE is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Please see full Prescribing Information, including Patient Information. You may report side effects related to AstraZeneca products (Opens new window).
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