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

Great NEWS today, relapsing English and Welsh CLL patients have a new treatment approved by NICE. Ireland and Scotland NHS access will soon follow.

NICE news article: Thousands of adults with chronic lymphocytic leukaemia to benefit from new treatment option

Thousands of people will benefit as NICE recommends venetoclax with rituximab for adults with relapsed or refractory chronic lymphocytic leukaemia.

It is estimated that around 1,000 people will be eligible for venetoclax in the first year and will be able to receive the treatment through the NHS.

The most common first line treatment for CLL is chemotherapy and there are limited options after relapse. Venetoclax, also known as Venclyxto and manufactured by AbbVie, will be offered in combination with rituximab to adults with relapsed or refractory CLL who have received at least one prior therapy.

People will be able to access venetoclax plus rituximab from today, just four months after marketing authorisation was granted in October 2018. Since April 2016 new arrangements with the Cancer Drugs Fund mean NICE aims to publish final guidance within 90 days of licence.

Read the full News article here nice.org.uk/news/article/th...

Following a first negative decision by NICE in 2018. Leukaemia Care, CLLSA and the clinical community have presented further evidence with the company to successfully overturn this to make this treatment available. You can read more within the committee papers and NICE final appraisal documents here : nice.org.uk/guidance/gid-ta...

Leukaemia Care Website article :

NHS England 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® ema.europa.eu/en/medicines/... , is produced by AbbVie. Rituximab was originally produced by Roche and is now also available to NHS in a biosimilar leukaemiacare.org.uk/wp-con... 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 full FAD document is available here. nice.org.uk/guidance/gid-ta...

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 2018 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 leukaemiacare.org.uk/wp-con... , 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 to advocacy@leukaemiacare.org.uk

•Call the helpline, free of charge on 08088 010 444 anytime. They will pass your enquiry onto the Patient Advocacy team.

Leukaemia Care information on chronic lymphocytic leukaemia (CLL), is available here. leukaemiacare.org.uk/suppor...

Nick

2 Replies
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This treatment option for relapsing English and Welsh CLL patients is absolutely brilliant news, thanks for letting us know. It also good to know that this treatment will soon be available in Ireland and Scotland too.

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Great news Nick, many thanks for letting us know all the detail.

Ernest

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