SMC approves venetoclax with obinutuzumab for some patients with untreated CLL

The Scottish Medicines Consortium (SMC) have today made recommendations for venetoclax plus obinutuzumab to become a treatment option for certain groups of chronic lymphocytic leukaemia (CLL) patients in Scotland.

The Scottish Medicines Consortium (SMC) have today made recommendations for venetoclax plus obinutuzumab to become a treatment option for certain groups of chronic lymphocytic leukaemia (CLL) patients in Scotland.

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 certain groups of untreated patients. These groups are:

  • patients with 17p deletion or TP53 mutations. These are genetic mutations that affect how well current treatments, such as FCR, work.
  • Patients who cannot have current treatments, such as FCR, for other reasons. For example, some patients are too unwell to have strong chemotherapy-based treatments or have other health conditions that mean FCR would make them very unwell, and so need to have alternative options for treatment.

However, we are disappointed that the treatment will not be available for those who are suitable for FCR as their alternative first treatment. The National Institute for Health Excellence (NICE) also recently approved this treatment combination for use in England. It was approved in England for all patients having their first treatment, rather than limited to the two groups under consideration here. NICE were able to consider this third group by using the Cancer Drugs Fund, which provides access to treatments whilst further information is gathered about how well it works. This was in part thanks to the work of patient groups, such as Leukaemia Care, and clinical experts.

Will this treatment be approved for the FCR-suitable population in the future?

This approval creates unacceptable differences between treatment options in England compared with Scotland. Whilst FCR is a treatment that is highly effective, it comes with side effects, some of which are long term, that many patients would like to avoid. Therefore, there is still an unmet need in the population of patients who would otherwise be treated with FCR.

Leukaemia Care will continue to work closely with AbbVie and the SMC to work towards greater access for patients.

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.

What is the evidence that the SMC used to make this recommendation?

The clinical evidence for this SMC 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 currently 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.

For further information about this decision or treatment, please contact our Advocacy Team at advocacy@leukaemiacare.org.uk

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