Calquence Tablet Formulation Receives Approval in European Union (EU)
Wednesday, February 22, 2023
AstraZeneca’s tablet formulation of Calquence (acalabrutinib) has been approved in the European Union (EU) for the treatment of adult patients with chronic lymphocytic leukaemia (CLL).
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. This 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.
In the trials, results showed the Calquence capsule and tablet formulations are bioequivalent, which indicated the same efficacy and safety profile 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). Most of the adverse events observed in these studies were mild and no new safety concerns were identified.
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.
