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Showing posts with the label Regulatory approval

AstraZeneca receives approval in EU for the First-Line Treatment of Chronic Lymphocytic Leukemia for the Fixed-Duration Acalabrutinib in combination with Venetoclax with or without Obinutuzumab

  AstraZeneca receives approval in EU for the First-Line Treatment of Chronic Lymphocytic Leukemia for the Fixed-Duration Regimen -  Acalabrutinib in combination with Venetoclax with or without Obinutuzumab.  Introduction Chronic lymphocytic leukemia (CLL) affects thousands across the European Union each year. It’s a slow-growing cancer that starts in the blood and bone marrow, often sneaking in with few symptoms. As treatments improve, patients now have better options for managing this disease. In recent years, the focus has shifted toward fixed-duration therapies. These treatments last for a set time, unlike continuous ones that go on until the disease progresses. Calquence (acalabrutinib), a targeted drug that blocks a protein called BTK, has gained attention for its use in CLL. Now, recent approvals make it possible to use Calquence for fixed durations in the EU. This article covers the approved Calquence regimens, examines the clinical data backing their use, a...