FDA Approves Indication for Acalabrutinib in Chronic Lymphocytic Leukemia
Posted: Thursday, November 21, 2019
Today, the U.S. Food and Drug Administration (FDA) approved a new indication for the Bruton’s tyrosine kinase inhibitor acalabrutinib (Calquence): treatment of adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) as an initial or subsequent therapy. This supplemental approval was granted as part of the FDA’s Project Orbis, a collaboration with the Australian Therapeutic Goods Administration and Health Canada.
The supplemental approval of acalabrutinib for patients with CLL was based on two randomized clinical trials that compared it with other standard treatments. The first clinical trial involved 535 patients with previously untreated CLL. Patients receiving acalabrutinib had a longer progression-free survival than did patients receiving other standard treatments. The second clinical trial included 310 patients with previously treated CLL. Patients receiving acalabrutinib also had a longer progression-free survival than patients receiving other standard treatments.
The most common side effects reported with acalabrutinib were anemia, neutropenia, upper respiratory tract infection, thrombocytopenia, headache, diarrhea, and musculoskeletal pain. Patients may experience atrial fibrillation and flutter and should be monitored for symptoms of arrhythmia. Patients also should be monitored for serious infections, bleeding, and low blood cell counts. In addition, patients should be advised to use sun protection while receiving acalabrutinib.
The FDA advises health-care professionals to inform women of reproductive age to use effective contraception during treatment with acalabrutinib. Women who are pregnant or breastfeeding should not take acalabrutinib.