FDA APPROVAL FOR ZANUBRUTINIB

[wizzard166]

Some of you may have seen the original News Release on January 19; however, for those who did not I'm presenting it here. Dana Farber announced that FDA Approval had been obtained for use of Zanubrutinib for those patients with relapsed CLL. The study showed that it was superior to the currently used Imbrutinib for those patients with relapsed CLL.

Here is the article:

dana-farber.org/newsroom/ne...

Carl

[SeymourB]

Wizzard166 -

I think it was approved for treatment naive patients, too, based on the SEQUOIA trial:

fda.gov/drugs/resources-inf...

[Research123]

It pleases me that there are so many improvements all the time with the treatment of CLL. I think now as technology increases the rate of improvement will just continue accelerating. There is an upside to it being such a common disease, which is that it makes it worthwhile for a huge amount of research to go into potential cures and treatments. We all just need to hold on, keep as healthy as we can and in the future our day will arrive.

[210savannah]

Question: If you are on Ibrutinib but your body becomes resistant and you have to change drugs, would this new Zanubrutinib be an option?

[michaeledward in reply to 210savannah]

I have the same question inasumuch as Ibrutinib seems to have lost its effectiveness for me.

[210savannah in reply to michaeledward]

I have been on Ibrutinib 4 years and still doing very well. I have been told it will one day lose its effectiveness for me, however.

[wizzard166 in reply to 210savannah]

I'm not a physician, but logically the answer would be yes. You should address that question right away to your current Oncology Specialist

Carl

[210savannah in reply to wizzard166]

My oncologist told me there were some new drugs that were effective but we didn’t have a lengthy discussion since Ibrutinib is still working for me. He said he didn’t want to change anything as well as I am doing now - been on Ibrutinib 4 years!

[AussieNeil Partner Administrator in reply to wizzard166]

Carl, michaeledward and 210savannah , if ibrutinib stops working for you because you develop resistance to it, then switching to zanubrutinib or acalabrutinib for that matter won't work either. That's because all of these BTKi drugs attach to the BTK enzyme in the same manner - covalently. You'd need to try one of the BTKi drugs which attach non-covalently. Most often they will work and there's a test available to determine what has caused resistance to develop. Importantly, the effectiveness of covalent bonding BTKi drugs wanes slowly. Sometimes you can experience tumour flare when you stop, so it's important to stay on your BTKi treatment until you have a replacement treatment.

We don't yet have any of the BTKi non-covalent drugs approved, but the approval for pirtobrutinib is anticipated fairly soon. So for the moment, access to non-covalent bonding BTKi drugs is through clinical trials, most of which are being conducted in the USA. It seems that you typically can count on around 5 years of use of a BTKi inhibitor, before needing to switch, though some who enrolled in the early ibrutinib clinical trials are into their second decade of successful treatment with ibrutinib. If you can't get access to a non-covalent bonding BTKi, the usual path is to switch to a BCL-2 class drug, which for the moment means venetoclax, though other BCL-2 drugs are going through clinical trials. For a comprehensive list of BTKi drugs approved and in clinical trials for CLL, see healthunlocked.com/cllsuppo...

There are replies to that post listing other treatment options approved and in clinical trials, with the first reply beginning "In the paper All in the family," healthunlocked.com/cllsuppo...

Neil

[KatieBlue in reply to 210savannah]

Just had a telehealth oncol appt where she brought up the possibility of switching to zanubrutinib. This was one part of the discussion— that if I didn’t switch now, and I became resistant to ibrutinib, then would zanabrutunib be an option. My oncol said that at that point it would not be an option and that I would need to move to an entirely different class of drugs.