AstraZeneca has made an important regulatory achievement with the European Commission (EC) approval of fixed-duration regimens of Calquence® (acalabrutinib) treatment for adult patients with untreated CLL. This action presents a new, time-limited treatment choice to EU patients with both clinical benefit and convenience.
The FDA specifically approved Calquence with venetoclax, with or without obinutuzumab. The fixed-duration treatment addresses one of CLL treatment’s central issues ongoing therapy burden by allowing predetermined treatment durations and hopefully enhancing long-term patient outcomes.
Supported by AMPLIFY Phase III Trial Data
The decision to approve was underpinned by results from the Phase III AMPLIFY trial, which compared fixed-duration Calquence and venetoclax (± obinutuzumab) with conventional chemoimmunotherapy. Three years after treatment, 77% of patients in the fixed-duration group had not had their cancer progress. This is a highly significant progression-free survival (PFS) benefit in this group of haematological cancers.
The trial also showed consistent safety results consistent with the established safety profile of Calquence, a very selective Bruton’s tyrosine kinase (BTK) inhibitor. The treatment was tolerable, and adverse effects were manageable, further supporting its appeal as a first-line regimen.
A Shift Toward Time-Limited Therapies
AstraZeneca highlighted the significance of this approval to the overall move toward finite treatment approaches in CLL. Ongoing therapy, although effective, can lead to cumulative toxicity, higher healthcare expenses, and decreased patient compliance. A fixed-duration regimen offers a valuable option, balancing efficacy with enhanced quality of life and lessened treatment weariness.
Growing Calquence’s Reach in Hematology
Calquence is already approved in over 50 countries for numerous indications across B-cell malignancies, including for previously untreated and relapsed/refractory CLL. The approval in the EU for use over fixed durations marks a significant shift in its treatment profile.
AstraZeneca’s growing hematology portfolio and ongoing dedication to the development of therapies for blood malignancies are also reflected in the approval. AstraZeneca is still dedicated to funding the investigation and creation of novel treatments that focus on important pathways like BTK inhibition.
About Calquence
Bruton’s tyrosine kinase (BTK) is selectively inhibited by Calquence (acalabrutinib), a second-generation inhibitor. Calquence inhibits BTK’s activity by binding to it covalently. BTK signaling causes the pathways required for B-cell adhesion, chemotaxis, trafficking, and proliferation to be activated in B-cells. Calquence is approved in the US, Japan, and China to treat small lymphocytic lymphoma (SLL) and chronic lymphocytic leukemia (CLL). It is also approved in the EU and numerous other countries to treat CLL. In the EU, calence is also authorized as a fixed-duration treatment for CLL in conjunction with venetoclax, either alone or in conjunction with obinutuzumab. In the United States, Europe, and other nations, Calquence is also authorized for the treatment of adult patients with untreated MCL. In China and a number of other nations, it is also authorized for the treatment of adult MCL patients who have had at least one previous therapy. In Japan, calquence is not yet authorized for the treatment of MCL.
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