The Food and Drug Administration (FDA) has approved a new tablet formulation of Calquence (acalabrutinib) for all current indications, including adult patients with chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL) and for patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least 1 prior therapy.
The approval was based on data from the 3 open-label, single-dose, crossover, phase 1 ELEVATE-PLUS trials, which showed the acalabrutinib 100mg tablets were bioequivalent to the currently marketed acalabrutinib 100mg capsules. The acalabrutinib tablets may be administered with proton pump inhibitors, antacids, and H2-receptor antagonists while the capsule formulation requires separating or avoiding the co-administration with these gastric acid reducing agents.
The safety profile of the tablet formulation was mild with no new safety concerns identified. The most common adverse reactions (incidence at least 30%) for acalabrutinib are anemia, neutropenia, upper respiratory tract infection, thrombocytopenia, headache, diarrhea, and musculoskeletal pain.
Calquence is currently available as 100mg capsules of acalabrutinib in 60-count bottles.
John C. Byrd, MD, Chair of the Department of Internal Medicine at the University of Cincinnati, said, “Patients with blood cancers like chronic lymphocytic leukemia and mantle cell lymphoma are often older and may face multiple medical conditions that may need intervention, including acid reflux or peptic ulcer disease. The US approval of acalabrutinib in a tablet form enables co-administration of the acalabrutinib tablet alongside a proton pump inhibitor.”
Calquence tablet formulation approved in the US across current indications. News release. AstraZeneca. Accessed August 5, 2022. https://www.astrazeneca.com/media-centre/press-releases/2022/calquence-tablet-formulation-approved-in-the-us-across-current-indications.html