NORTH CHICAGO, Ill., May 29, 2026
AbbVie announced that the European Commission (EC) has approved an expanded label for VENCLYXTO® (venetoclax), allowing its use in combination with acalabrutinib (with or without obinutuzumab) and ibrutinib for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL). The authorization broadens treatment options across European Union member states as well as Iceland, Norway, and Liechtenstein, providing additional fixed-duration, chemotherapy-free oral regimens designed to offer patients the possibility of treatment-free intervals.
Expanded Approval Adds New First-Line Treatment Options
The expanded approval is supported by data from the pivotal Phase 3 AMPLIFY, Phase 3 GLOW, and Phase 2 CAPTIVATE clinical trials. These studies demonstrated that VENCLYXTO-based combinations deliver durable disease control while reducing the burden associated with continuous therapy. According to AbbVie, the newly authorized all-oral regimens align with evolving treatment standards and provide physicians with greater flexibility when selecting personalized treatment strategies for newly diagnosed CLL patients. The approval further strengthens the role of venetoclax as a cornerstone therapy in the management of blood cancers.
Clinical Trials Demonstrate Durable Efficacy and Long-Term Benefits
The AMPLIFY trial showed that VENCLYXTO plus acalabrutinib reduced the risk of disease progression or death by 35% compared with chemoimmunotherapy, with median progression-free survival (PFS) not yet reached. In the GLOW study, the combination of VENCLYXTO and ibrutinib reduced the risk of disease progression or death by 73% and lowered the risk of death by 54% compared with chlorambucil plus obinutuzumab after more than five years of follow-up.
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Meanwhile, the CAPTIVATE trial reported a 5.5-year progression-free survival rate of 66% and an overall survival rate of 97%, with nearly three-quarters of patients remaining treatment-free years after completing therapy. These findings highlight the potential of fixed-duration regimens to provide long-lasting disease control without indefinite treatment.
Strengthening the Future of CLL Management
CLL remains one of the most common adult leukemias worldwide, and although significant advances have improved outcomes, the disease remains incurable. AbbVie stated that the expanded label reflects ongoing efforts to improve quality of life by offering treatment approaches that minimize long-term therapy exposure while maintaining efficacy.
Experts involved in the clinical programs emphasized that treatment-free periods can have meaningful benefits for patients and caregivers, reducing the physical and emotional burden of continuous cancer treatment. The latest approval reinforces AbbVie’s leadership in hematologic oncology and supports the growing adoption of targeted, chemotherapy-free therapies that are reshaping the treatment landscape for patients with chronic lymphocytic leukemia.
Source: AbbVie press release
