AstraZeneca Calquence tablet formulation approved in EU for adults with chronic lymphocytic leukaemia

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.

Calquence (acalabrutinib) is a next-generation, selective inhibitor of Bruton's tyrosine kinase (BTK).

Paolo Ghia, MD, Director, Strategic Research Program on CLL, Università Vita-Salute San Raffaele in Milan, said, “Many patients with chronic lymphocytic leukaemia face multiple medical conditions that require daily treatment, including the use of acid-reducing agents for conditions such as gastro-oesophageal reflux. The tablet formulation allows for co-administration with these drugs, allowing more patients with chronic lymphocytic leukaemia to assume Calquence.”

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “The Calquence tablet formulation underscores our commitment to understanding the needs of the chronic lymphocytic leukaemia community and providing patient-oriented treatment solutions. The approval offers physicians and patients in the EU more flexibility to determine the right treatment plan and enables more patients to potentially benefit from this medicine.”

Calquence is approved as a capsule formulation for CLL in the EU. It is also approved in the US as a capsule and tablet formulation for patients with CLL, small lymphocytic lymphoma (SLL) and relapsed or refractory mantle cell lymphoma (MCL). Additionally, Calquence is approved as a capsule formulation in many other countries worldwide. Indications may vary by market.