Business
AbbVie Announces European Commission Authorization of Expanded Label for VENCLYXTO® (venetoclax) to Include Additional Combinations in Previously Untreated Chronic Lymphocytic Leukemia
AbbVie Announces European Commission Authorization of Expanded Label for VENCLYXTO® (venetoclax) to Include Additional Combinations in Previously Untreated
About this update from Abbvie Inc.
[{"type":"text","content":"Addition of VENCLYXTO plus acalabrutinib, with or without obinutuzumab, and VENCLYXTO plus ibrutinib supported by data from Phase 3 AMPLIFY trial, Phase 3 GLOW trial and Phase 2 CAPTIVATE trialFixed-duration VENCLYXTO-based combination regimens provide patients with additional CLL treatment options that may offer the potential for treatment-free intervals NORTH CHICAGO, Ill., May 29, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the European Commission (EC) has authorized an expanded label for VENCLYXTO® (venetoclax) to include use in combination with acalabrutinib (with or without obinutuzumab) and use in combination with ibrutinib for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL). The expanded label follows the EC's inclusion of these combinations in the acalabrutinib and ibrutinib labels. These all-oral, fixed-duration combination regimens support current standards of care and offer patients and providers additional targeted oral medications for CLL in the first-line setting that include the potential for time off treatment.\nThe European Commission authorization extends to all European Union Member States, as well as Iceland, Norway and Liechtenstein.1\"VENCLYXTO-based combination regimens have demonstrated a favorable efficacy and safety profile in the first-line setting for chronic lymphocytic leukemia,\" said Svetlana Kobina, MD, PhD, vice president, global medical affairs, oncology, AbbVie. \"The inclusion of additional fixed-duration, chemotherapy-free, oral VENCLYXTO combinations in the label helps address the evolving needs of patients and healthcare providers, as they consider disease management options with the potential for treatment-free intervals. AbbVie is committed to transforming standards of care for people living with cancer, and the availability of all-oral VENCLYXTO combinations expands choice and flexibility for patients and providers navigating complex treatment decisions in CLL.\"VENCLYXTO in combination with acalabrutinib (with or without obinutuzumab) was supported by data from the Phase 3 AMPLIFY trial. VENCLYXTO in combination with ibrutinib was supported by data from the Phase 3 GLOW and Phase 2 CAPTIVATE trials.\"While CLL remains an incurable cancer and patients often relapse, it can be effectively managed with combination regimens, w...