AstraZeneca new tablet formulation of Calquence gets USFDA okay

The approval by the US Food and Drug Administration (USFDA) was based on results from the ELEVATE-PLUS trials presented during the 63rd American Society of Hematology (ASH) Annual Meeting & Exposition in December 2021.

In the trials, results showed the Calquence capsule and tablet formulations are bioequivalent, indicating the same efficacy and safety profile can be expected with the same dosing strength and schedule.

"The tablet can be taken with gastric acid-reducing agents, including proton pump inhibitors (PPIs), antacids and H2-receptor antagonists (H2RAs)," the company stated. The majority of observed adverse events (AEs) in these studies were mild with no new safety concerns identified.

John C. Byrd, MD, Chair of the Department of Internal Medicine at the University of Cincinnati said, "Patients with blood cancers like chronic lymphocytic leukaemia 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. This provides another option for some patients with chronic lymphocytic leukaemia and relapsed or refractory mantle cell lymphoma, enabling more patients to potentially benefit from this treatment."

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca said, "The approval of the new Calquence tablet formulation will offer physicians and patients increased flexibility when devising treatment plans for chronic lymphocytic leukaemia and mantle cell lymphoma. This new option is a result of our focus on understanding the wants and needs of this community and providing patient-focused solutions for their treatment."

Calquence is also approved as a capsule formulation for the same indications as the tablet in the US and in many other countries worldwide.3 Indications may vary by market.