EU Approves Acalabrutinib-Based Combinations for CLL
June 9, 2025
The EU commission has approved acalabrutinib in combination with venetoclax, with or without obinutuzumab, for the frontline treatment of CLL.
The EU commission has approved acalabrutinib in combination with venetoclax, with or without obinutuzumab, for the frontline treatment of CLL.
As Inflation Reduction Act negotiations begin, CLL Society is ensuring CMS understands the importance of treatments for CLL patients and physicians.
Acalabrutinib, venetoclax, and obinutuzumab is a highly active, time-limited frontline therapy for patients with high-risk CLL.
The AMPLIFY trial of acalabrutinib plus venetoclax, with or without obinutuzumab, could lead to the FDA approval of the first all-oral frontline CLL therapy.
Acalabrutinib plus obinutuzumab had a 100 percent response rate at 14 months and a deep reduction of disease in the bone marrow in treatment-naive CLL.
Resistance mutations in BTK and PLCG2 are common in patients with CLL who progress on acalabrutinib, a BTK inhibitor treatment that is taken continuously.
An interim analysis of the AMPLIFY trial comparing acalabrutinib and venetoclax with or without obinutuzumab for CLL shows improvements in patient survival.
A Matching-Adjusted Indirect Comparison (MAIC) Case Study: Zanubrutinib vs. Acalabrutinib Education Activity
Acalabrutinib may be taken alone or in combination with obinutuzumab as a preferred initial (first-line) treatment, or alone as a second- or thirdline treatment.
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CLL Society Inc. is a patient–centric, physician–curated nonprofit organization focused on patient education, support, and research. Dedicated to addressing the unmet needs of the chronic lymphocytic leukemia (CLL) and related blood cancer communities, we explain the rapidly changing therapeutic landscape and the importance of clinical trials, support and build patient networks, engage in research, and educate providers and patients.
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