AstraZeneca Calquence tablet formulation approved in EU for adults with chronic lymphocytic leukaemia
Calquence (acalabrutinib) is a next-generation, selective inhibitor of Bruton's tyrosine kinase (BTK).;
UK: AstraZeneca has announced that the tablet formulation of Calquence (acalabrutinib) has been approved in the European Union (EU) for the treatment of adult patients with chronic lymphocytic leukaemia (CLL).
The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use and is based on results from the ELEVATE-PLUS trials published in the American Society of Haematology journal, Blood.
In the trials, results showed the Calquence capsule and tablet formulations are bioequivalent, indicating the same efficacy and safety profile can be expected when prescribed 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.
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