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"Acalabrutinib + Venetoclax" Combination Therapy Receives Marketing Authorization for the First Time
2025-06-07 /
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Author：小编
AstraZeneca has announced the marketing authorization of its fixed-duration regimen comprising acalabrutinib and venetoclax (optionally combined with obinutuzumab) in the European Union. This regimen is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL). The approval is grounded in the findings of the Phase III AMPLIFY study, which demonstrated a remarkable three-year progression-free survival rate of 77% for the acalabrutinib + venetoclax combination, and an even higher rate of 83% when supplemented with obinutuzumab. In contrast, the standard chemoimmunotherapy group reported a survival rate of only 67%.
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