Calquence (acalabrutinib) is a small molecule Bruton tyrosine kinase inhibitor.
Calquence is specifically indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.
Calquence is supplied as a capsule for oral administration. The recommended dose is 100 mg orally approximately every twelve hours. The capsule should be swallowed whole with water and with or without food.
Calquence was granted accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. A phase II open label study enrolled a total of 124 patients with MCL who had received at least one prior therapy. Calquence was administered orally at 100 mg twice daily until disease progression or unacceptable toxicity. Tumor response was assessed according to the Lugano Classification for Non-Hodgkin’s lymphoma (NHL). The major efficacy outcome of the trial was overall response rate (ORR) and the median follow-up was 15.2 months. The ORR was achieved by 81% and 40% showed a Complete Response.
The FDA approval of Calquence for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) was based on the interim analyses of two Phase III clinical trials, ELEVATE-TN in patients with previously untreated CLL and ASCEND in patients with relapsed or refractory CLL. Together, the trials showed that Calquence in combination with obinutuzumab or as a monotherapy significantly reduced the relative risk of disease progression or death versus the comparator arms in both 1st-line and relapsed or refractory CLL.
Adverse effects associated with the use of Calquence my include, but are not limited to, the following:
Calquence (acalabrutinib) is a small molecule Bruton tyrosine kinase inhibitor. Acalabrutinib and its active metabolite, ACP-5862, form a covalent bond with a cysteine residue in the BTK active site, leading to inhibition of BTK enzymatic activity. BTK is a signaling molecule of the B cell antigen receptor (BCR) and cytokine receptor pathways. In B cells, BTK signaling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion.
For additional information regarding Calquence or mantle cell lymphoma, please visit https://www.calquence.com/