FDA label
What is Calquence used for?
Calquence contains acalabrutinib. The FDA-approved uses below are quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for Calquence lists 3 uses: Previously Untreated Mantle Cell Lymphoma; Previously Treated Mantle Cell Lymphoma; Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma.
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Calquence, tablet, film coated
Indications and Usage, quoted from the label by AstraZeneca Pharmaceuticals LP (NDA216387). Cross-references to other label sections are left out.
Previously Untreated Mantle Cell Lymphoma
CALQUENCE in combination with bendamustine and rituximab is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT).
Previously Treated Mantle Cell Lymphoma
CALQUENCE is indicated for the treatment of adult patients with MCL who have received at least one prior therapy.
Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
CALQUENCE is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Source: DailyMed label, set id b1409184-3267-4d8c-8f17-4e01f69828b1, version 9, effective February 19, 2026. NDC 0310-3512, one of 2 listings for this product.
Questions
What is Calquence used for?
The FDA label for Calquence lists 3 uses: Previously Untreated Mantle Cell Lymphoma; Previously Treated Mantle Cell Lymphoma; Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma.
What drug class is Calquence?
FDA lists acalabrutinib in the Kinase Inhibitor established pharmacologic class.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.