AbbVie has won European Commission approval to expand the label of VENCLYXTO (venetoclax), broadening its use in chronic lymphocytic leukemia (CLL) and adding new fixed-duration combination treatment options.
The approval authorizes VENCLYXTO for use in combination with acalabrutinib, with or without obinutuzumab, as well as in combination with ibrutinib for adults with previously untreated CLL. The decision applies across all European Union member states, along with Iceland, Norway and Liechtenstein.
The expanded indication is backed by data from the Phase 3 AMPLIFY and GLOW trials and the Phase 2 CAPTIVATE study, which demonstrated strong efficacy and safety outcomes while supporting a growing shift toward chemotherapy-free, time-limited treatment approaches.
"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."
The Phase 3 AMPLIFY study found that VENCLYXTO plus acalabrutinib reduced the risk of disease progression or death by 35% compared with standard chemoimmunotherapy. Median progression-free survival was not reached in the treatment arm, compared with 47.6 months for patients receiving chemoimmunotherapy.
Meanwhile, long-term data from the Phase 3 GLOW trial showed that VENCLYXTO plus ibrutinib reduced the risk of disease progression or death by 73% and lowered the risk of death by 54% compared with chlorambucil plus obinutuzumab. Patients receiving the combination achieved a median progression-free survival of 65 months, versus 23 months in the comparator group.
Results from the Phase 2 CAPTIVATE trial further reinforced the durability of the regimen, showing progression-free survival and overall survival rates of 66% and 97%, respectively, after 5.5 years. Nearly three-quarters of patients remained treatment-free more than five years after completing a 15-month course of therapy.
The approval comes as treatment strategies for CLL increasingly focus on balancing disease control with quality of life. Fixed-duration oral regimens offer the possibility of prolonged periods without treatment, reducing the burden associated with continuous therapy or repeated infusions.
"While CLL remains an incurable cancer and patients often relapse, it can be effectively managed with combination regimens, which have emerged as effective options to reduce the treatment burden for patients living with this disease," said Paolo Ghia, Professor of Medical Oncology at the Università Vita-Salute San Raffaele, AMPLIFY and CAPTIVATE steering committee member and investigator.
"With demonstrated durable responses in previously untreated patients and opportunity for treatment-free periods, these additional venetoclax-based combination regimens expand options for patients without the need for time-consuming infusions or continuous therapy."
Patient advocates also welcomed the move, highlighting the impact treatment-free intervals can have on daily life.
"People living with chronic lymphocytic leukemia can face multiple challenges when it comes to managing their disease, which can take a toll on a patient's mental health and overall well-being," said Jan Rynne, interim association development lead, European CLL Association.
"The possibility of time off treatment through additional combination treatment options has critical quality of life implications for patients and their families as they continue to navigate everyday life with CLL."
