Probably one of the best news stories that we have been able to announce in many years for patients in England and Wales.
We are absolutely delighted that this effective treatment is now available for ALL CLL patients as their first treatment if their doctor feels it is appropriate. This treatment is without restriction regarding fitness etc as so many others are but obviously your doctor will decide if this is suitable for you.
Patient and our charity advocacy was critical to this approval for all patients as the initial application was only for TP53/17p patients. However, CLL Support highlighted that there were severe inequalities in access to novel therapies in the UK for younger fitter patients who had no right of access to a novel therapy and could still be treated with FCR in some hospitals.
Nice reported the following in their papers:
Q: Have the potential equality issues identified during the scoping process been addressed by the committee, and, if so, how?
A: During scoping consultation, a consultee highlighted an urgent need for access to novel treatments for younger, fitter patients with chronic lymphocytic leukaemia as currently only fludarabine, cyclophosphamide and rituximab (FCR) or venetoclax plus obinutuzumab via the Cancer Drugs Fund is available to them. This has been addressed by committee because ibrutinib plus venetoclax has been recommended for everyone with untreated chronic lymphocytic leukaemia.
Please ask your doctor if this is suitable for you if you are approaching treatment for the first time.
Jackie
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Jm954
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This is absolutely monumental news for CLL patients in the U.K. Jackie and your contribution to this has been immense. Do we need to wonder who the ‘consultee’ was who pointed out the inequities of not including younger, fitter patients to receive I&V? 😉
As a recipient of Ibrutinib and Venetoclax first line treatment as part of a clinical trial, I appreciate just how fortunate I’ve been. It’s clear that results from this combination are remarkable even for aggressive markers and help us achieve durable remissions without recourse to chemo. I’m delighted to hear that it will now be available more widely outside of a clinical trial.
Huge thanks for your skilled dedication to the submission. This is very important news and we should be absolutely delighted to hear it! 👍😊
I know Professor Peter Hillmen was involved in developing the trials. He has left front line medicine, but hats off to him and all the other researchers who embarked on the combination strategy. For newly diagnosed CLL patients, the end of Chemo is game changing.
Yes we owe a debt of gratitude to Prof Hillmen and many other researchers for their pioneering work. After hearing him speak at a CLL Association conference in Leeds, I managed to later receive a second opinion from him before enlisting on his Flair Trial in 2019. Fortunately I was assigned to the I&V arm of the trial. My option without this as a younger patient without a TP53 deletion would have been FCR.
my story is similar. I was about embark on FCR, when I had a second view from Peter. I was on W&W for a further year, and was lucky to have private health care they allowed me to stay with Peter. After 18 months on Ibrutinib, I am now in remissions with a potential of 24-48 months treatment free. My new consultant Tal has discussed the potential to use the combination for when my next treatment is required, and see if we can push it into deep remission. However I will need to wait for the trails of Acalabrutinib and Zanabrutinib in combination with Venetoclax to complete.
I needed treatment at the same time as you Newdawn. I had already had fcr in 2009/2010 and had UMRD but it was those on this site along with others that got Ibrutinib agreed for 2nd line treatment. I am lucky that I have responded both times I have needed treatment. I am in remission and I was told I would be given Venetaclax next time. I try not to think about it but it would be good if Venetaclax could be added on to Ibrutinib when it starts to fail. We dont get the treatments that are available in the a USA and as I am doing ok I hope the treatments will be there when I need them. Thankyou Jackie. Anne uk
Great news and thank you for your redoubtable campaigning . Is this combination being researched separately for the other 'brutinibs?
Also, I wonder what is at stake in terms of combining them in terms of overall treatment time - i.e. do you get longer remission by combining them or taking V when I fails? Or, what is next in line if/when V + I fails?
Yes, there are a number of trials with different BTK's. There's so much interest, in the US at least one trial is *paying for our already FDA approved* drugs, which generally doesn't happen here.
One of the big bonuses in combining them in a time limited course is you can then get off of them ahead of resistance developing. You can use them again in combination in the future having not burned any options. The reuse trials are showing great results.
Hi thank you so much Jackie for informing us of this and for all of your efforts to get it approved for first line treatment.
I am aware there is a trial looking at adding venetoclax to ibrutinib for those already on ibrutinib, CAPTIVATE. Hopefully this will be offered to those of us using ibrutinib in the future should it prove beneficial?
After reading that Venetaclax could be added to Ibrutinib, it looked promising that when the Ibrutinib began to be resistent, Venetaclax would start it working again. It gives hope to many, Anne uk
Hi Jm954, I wonder if I might qualify for a change to this new treatment. I have been on Ibrutinib for 10 years or so and still believe many of my side effects are related to the Ibrutinib. In the past when I have raised the issue with my haematologist she has simply responded with do you want to stop the treatment? I will of course pose this question to her at my next appointment.
I asked about stop and start and was told I would lose my funding if I stopped for more than 6 weeks. My dose was reduced to 140 mg and I have stayed in remission. The pain in my joints is not often now. Thankyou, Anne uk
Hi Jackie, yes I have been very fortunate that the Ibrutinib has worked well for me. Unfortunately my pre-existing symptoms of my Behcets have worsened since treatment for my CLL to the point that I am in constant pain and struggling with my mobility. Is it the Ibrutinib or other medication causing my issues ? no one can really say for sure which is why I asked if I could have a break from the treatment but was told I would probably loose the funding. I will however raise the issue again with the medic’s.
Hi Jackie, many thanks for your response and the mention of a new Behcets medication.
I have written a post or two in the past regarding my Behcets and CLL Outlining the background history of how I have struggled with both conditions.
The Behcets goes back to my childhood but became a real disability to me from the mid 1960’s. I had been treated at QMH at Roehampton but in 1990 my then GP became a fund holder and stopped my hospital appointments saying “as your Behcets is an incurable condition” I can treat you myself and save money.
The treatment he referred to was my regular INR tests as I was on lifetime anticoagulation treatment.
In 2000 I was struggling and asked to be referred to Sara Deacocks immunology clinic at the Royal Surrey hospital. It was they who diagnosed my Leukaemia.
It was whilst being treated at the Royal Marsden hospital that they wanted me to be referred to the Behcets centre of excellence at the Royal London hospital to ascertain the causes of my symptoms, as I was already requesting the Ibrutinib trial to be stopped as I believed this was making life worse.
In a nutshell they said that the Leukaemia had dampened down the Behcets adding that my symptoms were related to the CLL and too much toxic medication.
So this is roughly where I am today. I’m in constant pain, head to toe, peripheral nerve damage and spinal issues not unlike those suffered by our own Newdawn.
However, one light in the tunnel, I received a letter yesterday to say I have been referred to the waiting list for nerve denervation procedure, maybe, just maybe this will alleviate one of my issues that has plagued me since the mid 1980’s.
I'm so sorry to hear of your longstanding painful issues. Your GP sounds heartless, I was working in the NHS when GP Fundholding was introduced and the greedy side of GPs, often over the welfare of their patients, became very apparent then. Typically, if they weren't't given free services they threatened to send patients elsewhere, although I must emphasise that this wasn't true for all of them.
My friend's daughter has very severe Bechet's and I know how awful it can be.
I hope you get an appointment soon for the nerve denervation procedure. My advice would be DO NOT minimise your symptoms and how it affects you, in fact paint the worst possible picture so that you get access to it and soon.
Jackie, just want to say that for me personally the medical care I received from the mid 1960’s up until the creation of GP fund holding was far more person centred.
My current GP cannot refer me directly to any of my NHS services that have been treating me over the years. My GP can only request the patient referral team to refer me.
When I asked to be re-referred to the Marsden dermatology as advised by them because I thought I might have another skin cancer issue I was told by the referral team”we have no patient pathways by which we can refer you to the NHS”.
Lastly, I empathise with your friends daughter as I know the effects of Behcets and how they are often worse for women.
Hi Anne, yes I too have been on a reduced dose in the past and have asked if I can go back on 140mg again but it’s not happened. I do know from others on this site who are on 140mg on alternate days.
I read your previous posts and I get problems with pain in my hands and fingers. My wrists are painful and I am in danger of droping cups. This started when I began Ibrutinib. My fingers were curled up and I had knee pain. I couldnt drive.A lower dose has helped but hasnt cured it. I think Ibrutinib attacks the weakest places. I have had surgery on my discs and my back is unstable. My back goes into spasm and I am in agony at times. . I have lots of aches and pains at the moment. I was a lot better 3 days ago.
Despite this I am grateful to have Ibrutinib. As I am in remission, there wouldnt be any need to change meds. I hope when the time comes I can have a combination.
Its brilliant getting these 2 drugs. I hope you get sorted with drugs you cope with, Anne uk
Hi Anne, thanks for viewing my posts and highlighting any common symptoms which is something I very much hoped would result.
Yes, muscle spasms are still with me, hands, feet and muscles in my torso even after all this time on Ibrutinib not forgetting of course I’m stilled plagued daily with a sore mouth and erratic BP etc.
The last few years have seen more pain in my hands and fingers I can barely grip things and the pain radiates into the tips of my fingers and under my nails.
But again, like you the Ibrutinib has been successful in treating my CLL.
Thank you so much for all your campaigning, you have everyone’s gratitude I am sure.
I feel I benefited from the only good thing to come out of Covid - I got Acalabrutinib as a first line drug (because they didn’t want us going into hospital on FCF in the pandemic). I am so glad that I am on Acalabrutinib and doing well and delighted that others can now have this drug too.
Absolutely fantastic news!! It also made me realise how fortunate we were that my son got the treatment on a trail as, at his age, he probably wouldn’t have stood a chance otherwise. Do Scotland and Northern Ireland have to approve it separately, do you know?
Thank you Jackie- for the post and your campaigning. This is not just a a ‘big thing’ for those about to start treatment or in treatment. For those of us in watch and wait it’s a relief that we at least have the possibility if not certainty of avoiding chemotherapy.
At my diagnosis consultation CLL was downplayed because of the novel treatments available. i was dismayed when I started my research that UK didn’t offer this as first treatment. it has been a bigger worry for me than the disease itself.
I can possibly consider my early retirement plans if i no longer need employer health cover to get the treatment I want 😀
this is great news. Thank you for your work on this. I was at the Marsden on Monday. My numbers have happily improved so I continue on W&W but was told of this new possibility for when the time comes to treat. Keith
this has been approved very quickly and they didn’t wait for the long term data to make a decision. They’ve moved faster than the USA FDA on this occasion.
I agree but look how long it took to approve BTK inhibitors, and then only for the patients with high risk. I still feel that the NHS has continued with FCR for way too long, considering the evidence for the new generations of drugs.
Jackie, do you know if they plan to license I & V for relapsing/refractory CLL?
I do hope we don't end up in the situation like we are for V & O, where they only got a license for first line treatment - not including R/R CLL - so relapsers have to go back to Rituzumab.
Jackie, that’s wonderful news. Can I add my thanks for everything you’ve done to push this. I’ve been W&W for 3 years now and with levels changing rapidly, symptoms developing and treatment a distinct possibility. This is just the best news for anyone in my position right now. Huge thanks.
Thank you Jackie for this. I was wondering how this will impact on the use of Acalabrutinib. I thought Acalabrutinib had replaced Ibrutinib due to less adverse side effects. Will front line treatments now go back to Ibrutinib plus venetoclax and Acalabrutinib be dropped? For those of us just on Acalabrutinib will there be any chance of adding Venetoclax and hopefully uMRD and get back on WandW?
Kate, I cannot see Venetoclax being added to Acalabrutinib (or even Ibrutinib) because that combination is not licensed. I+V would need to be the treatment plan from the start.
The use of Ibrutinib in this combination is because that is the combination used in the trial. The usual problems and cautions about Ibrutinib will apply and so it won't be suitable for everyone. It's also pretty intense but ideal for high risk patients.
Do we have any evidence as to the long-term advantages/disadvantages or combining them, vs having V when I fails (or vice versa)? The question is really whether it is optimal, in terms of duration of response, to use two major treatment options at the same time or take them sequentially?
This is amazing news. Thank you for sharing and for all the hard work you do Jackie.
This is an amazing group with a lot of very altruistic members. I consider myself so lucky to have found it. The information given by so many people means that the future can be thought of with at least a little less dread. I’m totally blown away at how in the 8 (nearly) years since diagnosis, treatment opportunities have changed so dramatically.
Such GREAT news !!! Sooooooo exciting!!! I was a part of Dr Coutre’s Ibrutinib/Venetoclax trial at Stanford He was also responsible for the drugs, the combination and of course for saving my life I am very grateful and blessed to have gone through it I am so happy many others will now get to enjoy a deep remission 🎉Catnap7 🐈🐈
MEGA andTHRILLING news. Not enough thank yous can be said for the hard work and expertise from all who worked on this achievement (very much including the scientists)
it’s quite intensive so you would need to be going into treatment reasonably fit and well but the best thing to do is ask. If the answer is no,then ask why not.
Thanks for the good advice. I appreciate it. I’m a bit low at the moment with viral conjunctivitis. The doctor I spoke to was concerned about that. I’ve got to have another blood test in a month when, hopefully, it will have cleared up.
Possibly a daft question, does anyone know if this means that we no longer need watch and wait?
When I was diagnosed in 2015 it was my understanding that w&w was used because FCR / chemo could only be tolerated for three lots of treatment and so it was important not to treat too early.
I have a pretty poor quality of life (fatigue/weakness mainly) despite my blood work all being only a touch outside normal for the last 6 years.
I would be tempted to come off watch and wait if it’s no longer a matter of “starting the clock” on available treatments.
Does anyone know if this does impact watch and wait?
For those with aggressive CLL, there still remains the potential issue of running out of approved treatment options if they don't make the most of their watch and wait period before commencing their first line of treatment. Currently, there's a recognised need for new treatment options for those who have CLL which has become refractory (resistant to) BTKi drugs (the 'inibs" and BCL-2 treatment, currently just venetoclax. This is why the triggers for commencing treatment weren't changed in the iwCLL Guidelines in the most recent 2018 update, despite some considering that changes in that section might occur. While it has been five years since that last iwCLL update, as Jackie has pointed out, healthunlocked.com/cllsuppo..."New trials are taking place but it can take many, many years for a significant difference to become apparent.", so it might be a while yet before we see a change to official recommendations.
This lack of a move to earlier treatment might seem like discouraging news, but it's actually a reflection of having a chronic cancer; whether or not you have early treatment, it can take upwards of 10 or more years for any benefits of early treatment to become apparent.
Previous trials have shown no benefit to starting treatment earlier than the guidelines suggest, however most of those were using chemotherapy. New trials are taking place but it can take many, many years for a significant difference to become apparent.
If your quality of life is very impaired speak to your doctor about treatment. Ironically you need to be fairly fit and well to tolerate this treatment as it’s quite intense.
The most important thing, apart from the ones you mention was the fact that NICE addressed the health inequity issues for younger fitter patients. The use of MRD negativity was a surrogate marker of progression free survival. It was a great result.
The price negotiations are a tightly kept secret but I don't think it will have been much different.
Ibrutinib was coming off patent but a recent statement says "no generic entry for any Imbruvica product is expected prior to March 30, 2032,” thanks to prior settlements with generic makers."
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