NICE use the Cancer Drugs Fund to grant access to venetoclax for treating chronic lymphocytic leukaemia patients.

[HAIRBEAR_UK]

Some good news!

Today the National Institute for Health and Care Excellence (NICE) published the Final Appraisal Determination (FAD) recommending venetoclax (Venclyxto) be made available to treat chronic lymphocytic leukaemia. Access has been granted via the Cancer Drugs fund, through a managed access program. This enables accelerated access to the treatment by CLL patients and their doctors whilst additional data is collected.

We have published a news article and summary for you here: - leukaemiacare.org.uk/news/n...

In Brief

NICE recommendations

1.1 Venetoclax is recommended for use within the Cancer Drugs Fund, within its marketing authorisation, as an option for treating chronic lymphocytic leukaemia; that is in adults:

•with a 17p deletion or TP53 mutation and when a B-cell receptor pathway inhibitor is unsuitable, or whose disease has progressed after a B-cell receptor pathway inhibitor or

•without a 17p deletion or TP53 mutation, and whose disease has progressed after both chemo-immunotherapy and a B-cell receptor pathway inhibitor and

•only if the conditions in the managed access agreement are followed.

When a treatment is approved for use within the Cancer Drugs Fund, NHS England make it available according to the conditions in the managed access agreement. If a patient has chronic lymphocytic leukaemia and their doctor thinks that venetoclax is the right treatment, it can now be accessed in line with the above recommendations.

Venetoclax is anticipated to remain available through the CDF during the data collection period until December 2020 and during a subsequent appraisal, while the final guidance is reviewed. A final decision is expected in early 2021.

Read completed article: - leukaemiacare.org.uk/news/n...

The complete Guidance FAD document, committee papers and managed access agreement can be accessed here: nice.org.uk/guidance/gid-ta...

Nick

:

[lankisterguy]

Great News Nick,

Now we can have patients from the UK join our MRD neg and No More Ven clubs!

Len

[HAIRBEAR_UK in reply to lankisterguy]

Hi Len indeed, Numbers will be growing There is a growing UK population that have been on V for a while as the Early Access to Medicines Scheme and a compassionate access programme have allowed access over the past year.. We are now going to see more success stories, fingers crossed

Nick

[Fit440]

Are there any statistics available on this drug?

[lankisterguy]

Here is an article by my Dr. that includes a link to his paper at ASCO with statistics.

cornell-lymphoma.com/tag/ri...

clincancerres.aacrjournals....

As a single agent, daily venetoclax treatment

induced durable responses in 79% of patients with relapsed or refractory CLL or small lymphocytic lymphoma in a Phase 1 study, including complete remissions in 20% of patients.

Its use was approved by the FDA in April 2016 for patients with previously treated del(17p)

CLL on the basis of a single arm Phase 2 trial demonstrating a 79% response rate and an estimated 1 year progression-free survival of 72% with 400mg/day continuous therapy.

hematologyandoncology.net/a...

In the 2 published clinical trials evaluating venetoclax monotherapy (Roberts and colleagues24 and Stilgenbauer and colleagues25), the overall response rates were high (79% in both studies) in patients with high rates of negative prognostic factors, including resistance to fludarabine, chromosome 17p deletion, unmutated immunoglobulin heavy chain variable region gene (IGHV), and bulky adenopathy. Further, a deep remission was achieved in a substantial percentage of patients, including a fraction of patients with a complete remission (20% and 10%, respectively). Preliminary results of a study of venetoclax monotherapy in patients with CLL whose disease had relapsed after or progressed during treatment with either ibrutinib or idelalisib indicate that venetoclax is also safe and effective in this population with highly refractory disease.28 An overall response rate of 67% to 70% was demonstrated at 24 weeks in 39 patients on venetoclax and previously treated with ibrutinib. Similarly, an overall response rate of 48% to 57% was achieved in 21 patients previously treated with idelalisib and then treated with venetoclax during this same period.

And of course the PR release from Abbvie

news.abbvie.com/news/abbvie...

Len