European Commission Approves Fixed-Duration Regimen of Calquence and Venetoclax for Chronic Lymphocytic Leukemia

The European Commission (EC) has approved a fixed-duration treatment regimen combining AstraZeneca’s Calquence (acalabrutinib) with venetoclax for patients diagnosed with chronic lymphocytic leukemia (CLL). The decision marks a significant regulatory milestone for the use of this combination therapy in managing the disease.

The approval allows the use of acalabrutinib, a Bruton’s tyrosine kinase inhibitor, alongside venetoclax, which targets B-cell lymphoma-2 proteins, as part of a defined treatment period. This regimen is designed to provide an alternative therapeutic option for individuals living with CLL. Chronic lymphocytic leukemia is one of the most common types of leukemia in adults and often requires long-term management strategies. The EC’s decision follows a thorough evaluation process and reflects growing interest in fixed-duration therapies that aim to balance efficacy with reduced treatment burden.

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Source: GO-AI-ne1

Date: June 9, 2025

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Mark Chiang