Calquence tablet formulation approved in the US across current indications,- AstraZeneca

Complete Response Letter from FDA for sNDA for pimavanserin for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosisThe approval by the FDA 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 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.”

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