NICE approves venetoclax (VENCLYXTO) with rituximab for previously treated chronic lymphocytic leukaemia (CLL) patients

NHS England are to make the first targeted CLL chemotherapy-free combination treatment of a fixed duration available through routine commissioning to treat patients relapsing or failing a first treatment

Today the National Institute for Health and Care Excellence (NICE) published the Final Appraisal Document (FAD) approving the use of venetoclax with rituximab to treat relapsed and refractory chronic lymphocytic leukaemia (CLL) patients in England. They concluded that venetoclax plus rituximab is a cost-effective use of NHS resources and is recommended for routine commissioning.

NICE recommendation states:

“Venetoclax with rituximab is recommended, within its marketing authorisation, as an option for treating chronic lymphocytic leukaemia in adults who have had at least 1 previous therapy.”

Venetoclax otherwise known as Venclyxto®, is produced by AbbVie. Rituximab was originally produced by Roche and is now also available to NHS in a biosimilar form from other manufacturers. Both are types of targeted drugs.

Venetoclax is an oral BCL-2 inhibitor. The BCL-2 cellular protein prevents apoptosis (programmed cell death) causing CLL cells to accumulate. This medicine restores the death instinct in the CLL cells. Rituximab is a monoclonal antibody, rituximab targets a protein called CD20 on the surface of the leukaemia cells. The antibody sticks to the CD20 proteins it finds, then the cells of the immune system pick out the marked cells and kill them.

The FAD document and committee papers can be accessed here.

Venetoclax was also approved in 2017 by NICE for use as a single agent to treat CLL patients with a 17p deletion or TP53 mutation and if unsuitable for, or if relapsed from a B-cell receptor (BCR) pathway inhibitor treatment. Venetoclax as a single agent was also approved in 2017 to treat CLL patients without a 17p deletion or TP53 mutation in the relapsed setting, but only patients relapsing from 2 lines of previous therapy, both a chemo-immunotherapy and BCR inhibitor.

Alternative options for treating second line CLL patients today typically involve continuous treatment with the targeted non-chemotherapy drug ibrutinib. For patients seeking a treatment free period, retreatment with a chemo-immunotherapy is the only option, which is often unsuitable. Today’s decision by NICE is a significant change in CLL treatment and how it may be managed into the future.  Patients who have received at least one prior therapy, now have NHS access through routine commissioning to a chemotherapy-free targeted combination treatment. The treatment is for a fixed term of 24 months and offers potential for a treatment free period.

The NICE recommendation to make venetoclax plus rituximab available was based upon MURANO Phase 3 clinical trial data. The trial compared venetoclax plus rituximab treated patients to bendamustine plus rituximab treated patients. The primary outcome measure in MURANO was progression-free survival (PFS). At the time of the analysis, the trial demonstrated an eighty-three percent reduction in the risk of disease progression or and prolonged overall survival (OS) compared to the standard of care. At 36 months 60% of venetoclax plus rituximab patients in the trial had undetectable minimal residual disease, which is a strong predictor of lasting remission in patients with chronic lymphocytic leukaemia.

Nick York, a chronic lymphocytic leukaemia patient working at Leukaemia Care commented:

“Leukaemia Care welcome NICE’s decision to make this important treatment available to patients relapsing or failing after first treatment. This is a major step change for CLL treatment and has the potential to transform how the disease is managed and treated. Patients worry of relapse and what may come next. Access to a chemotherapy-free option which offers the potential of a treatment break, will uplift the community and improve patients’ quality of life”.

For further information, please contact our Patient Advocacy team. They are available Monday to Friday from 9:00am – 5:30pm. If you would like to contact them, you can:

  • Call our office line on 01905 755977
  • Send them an email
  • Call the helpline, free of charge on 08088 010 444 anytime. They will pass your enquiry onto the Patient Advocacy team.

For more information on chronic lymphocytic leukaemia (CLL), please click here.

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