AstraZeneca's BTK Inhibitor Calquence Receives EU Approval for Chronic Lymphocytic Leukemia
AstraZeneca
Biopharmaceutical Manufacturer
European Commission
The European Commission, abbreviated as the EU Commission, is a supranational body under the European Union. Within the EU political system, the European Commission primarily undertakes executive tasks, thus being roughly equivalent to the government in a national system. However, the European Commission has other functions as well. In particular, except for the few circumstances specified in the treaties, the European Commission is the only institution with legislative power in the EU legislative process.
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On November 9, AstraZeneca’s targeted anticancer drug Calquence (acalabrutinib) received approval from the European Commission. As a next-generation selective Bruton’s tyrosine kinase (BTK) inhibitor, it is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL), the most common type of leukemia in adults. This approval provides a new chemotherapy-free treatment option for CLL patients in Europe.
This approval is based on the positive results from two Phase III clinical trials (ELEVATE-TN and ASCEND). The data demonstrated that, compared with standard of care, Calquence showed superior progression-free survival (PFS) and favorable tolerability in both treatment-naïve patients with chronic lymphocytic leukemia (CLL) and those with relapsed or refractory CLL. The interim results of these two studies were published respectively in The Lancet and the Journal of Clinical Oncology (JCO).
The ELEVATE-TN Phase 3 trial, conducted in previously untreated patients with chronic lymphocytic leukemia (CLL), demonstrated that, compared with chlorambucil plus obinutuzumab (a chemotherapy-based regimen), Calquence plus obinutuzumab and Calquence monotherapy significantly reduced the risk of disease progression or death by 90% and 80%, respectively.
The ASCEND Phase 3 trial was conducted in patients with relapsed or refractory CLL. The data showed that at 12 months, 88% of patients in the Calquence treatment group were progression-free, compared to 68% in the control group (IdR [rituximab + idelalisib] or BR [rituximab + bendamustine]).
Calquence is a highly selective, potent, covalent BTK inhibitor that binds covalently to BTK to inhibit its activity. BTK is a key regulator of the B-cell receptor (BCR) signaling pathway and is widely expressed in various types of hematologic malignancies. It plays a role in B-cell proliferation, trafficking, chemotaxis, and adhesion, making it an important therapeutic target for the treatment of hematologic malignancies.
Calquence has been approved in the United States for the treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL), and it has also been approved for the treatment of CLL in several other countries. Additionally, Calquence has been approved in the United States and several other countries for the treatment of adult patients with mantle cell lymphoma (MCL).
As part of an extensive clinical development program, Calquence is currently being evaluated in more than 20 clinical studies for the second-line treatment of B-cell malignancies, including chronic lymphocytic leukemia (CLL), mantle cell lymphoma (MCL), diffuse large B-cell lymphoma (DLBCL), Waldenström macroglobulinemia (WM), follicular lymphoma (FL), and other hematologic malignancies.
Reference source: Calquence approved in the EU for the treatment of chronic lymphocytic leukaemia
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