NICE approves venetoclax with obinutuzumab for patients with untreated CLL

The National Institute for Health and Care Excellence (NICE) have made recommendations for venetoclax plus obinutuzumab as an option for chronic lymphocytic leukaemia (CLL) patients in England.

The National Institute for Health and Care Excellence (NICE) have made recommendations for venetoclax plus obinutuzumab 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.

Which group of patients can access this new treatment?

It 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.

This recommendation also gives access to CLL patients who would otherwise be suitable for the FCR or bendamustine and rituximab (BR). Access for this group is being funded through the Cancer Drugs Fund (CDF). This is good news; initially these patients were not being considered in the NICE appraisal, as there was less clinical trial data available about venetoclax and obinutuzumab in this population. The patient groups, including Leukaemia Care, and the clinical experts pushed hard for this group of patients to be considered as well, as further data could be collected whilst giving some patients access using the CDF (see below for more information). This recommendation shows that this work has had an impact upon the NICE recommendation and further patients will have access as a result.

What is the CDF?

Cancer Drugs Fund (CDF) is a funding source for promising new cancer treatments. If there are any uncertainties about the effectiveness of a new treatment, the treatment can still be funded by the CDF whilst new or additional data is collected. This allows patients to access the treatment, in the meantime. NICE can then consider whether the treatment should be routinely funded by the NHS once the data is collected, usually after 2 to 3 years.

How does this combination of drugs work?

Venetoclax is an oral BCL-2 inhibitor. The BCL-2 protein prevents programmed cell death and thereby supports the survival of leukaemia cells. Venetoclax inhibits and blocks this activity of the BCL-2 protein, causing cell death of CLL cells. Obinutuzumab is a monoclonal antibody that targets the CD20 protein on the surface of leukaemia cells. It marks the cell for destruction by the immune system.

Why has NICE made this recommendation?

The clinical evidence for this NICE recommendation came mainly from the CLL14 clinical trial, which compared venetoclax and obinutuzumab against obinutuzumab plus chlorambucil. The trial showed a significant improvement in progression-free survival (i.e. an increase in the length of time people survive without their CLL getting worse) in patients who took venetoclax plus obinutuzumab.

Treatment options offered to patients with untreated CLL vary, depending on factors such as their genetic mutational status and whether or not they are able to tolerate a chemotherapy based treatment. Most of the newer, non-chemotherapy treatments, such as ibrutinib and other combinations of venetoclax are only available if you have relapsed from other treatment 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 that other treatments.

Further information and documents about this recommendation can be accessed here.

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