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The National Institute for Health and Care Excellence (NICE) has approved venetoclax plus obinutuzumab. It is approved as an option for chronic lymphocytic leukaemia (CLL) patients in England.
The brand name for venetoclax is Venclyxto® and it is produced by AbbVie. The brand name of obinutuzumab is Gazyvaro® and it is produced by Roche.
I have CLL, can I access this new treatment?
Ventoclax with obintuzumab is recommended for untreated patients. This includes patients with and patients without 17p deletion or TP53 mutation. These are genetic mutations that affect a person’s response to chemotherapy treatments.
As of 15th December 2025, NICE also gives access to CLL patients who would otherwise be suitable for FCR or bendamustine and rituximab (BR). Treatment was available temporarily whilst more data was collected. Now anyone with untreated CLL can have ventoclax with obinutuzumab if their doctor considers the treatment as appropriate for them.
Who was involved in making this decision?
The patient groups including Leukaemia Care and the clinical experts pushed hard for all groups of patients to have access. This recommendation shows that this work has had an impact upon the NICE recommendation. Further patients will have access as a result.
How does this combination of drugs work?
Venetoclax is an oral BCL-2 inhibitor. The BCL-2 protein supports the survival of leukaemia cells. Venetoclax blocks this activity of the BCL-2 protein, causing cell death of CLL cells. Obinutuzumab is a monoclonal antibody. It targets the CD20 protein on the surface of leukaemia cells. It marks the cell for destruction by the immune system. The drugs together target the leukaemia in 2 ways, increasing the chance of killing cells.
Why has NICE made this recommendation?
The clinical evidence for this recommendation originated from the CLL14 clinical trial. This trial compared venetoclax and obinutuzumab against obinutuzumab plus chlorambucil. Venetoclax with obintuzumab showed a significant improvement in time that people survive without their CLL getting worse . The decision to make venetoclax and obinutuzumab available longer term is thanks to the data collected whilst the treatment was temporarily available.
Treatment options offered to patients with untreated CLL vary. It depends on factors such as:
- their genetic mutational status
- and whether they are able to tolerate a chemotherapy based treatment.
Many of the newer, non-chemotherapy treatments are only available if you have relapsed from other treatments or cannot tolerate chemotherapy. This combination of venetoclax and obinutuzumab offers treatment option that is:
- only taken for a fixed amount of time
- which can be better tolerated and
- have fewer long term side effects than other older treatments.