Early CLL Treatment Options: What to Know

[Smakwater]

More interesting "I thought So's" from Patient Power - One point on early treatment and fatigue.

Check it out - patientpower.info/video/chr...

[may04cll]

so what is the hold up for ibrutinib plus venetoclax approval ?

[Smakwater in reply to may04cll]

FDA is the hold up, however, the combination can be administered off label.

[BigfootT in reply to may04cll]

Ibrutinib + Venetoclax won't be approved in the US. We are waiting for Acalabrutinib + Venetoclax approval.

[Smakwater in reply to BigfootT]

Agreed!

[may04cll in reply to BigfootT]

could you explain why one and not the other ?

[Zweistein in reply to may04cll]

Side effects.

[Smakwater in reply to may04cll]

In simple terms Zweistein nailed it, However, we are all individual and some do better on drugs that are not necessarily showing favor in the matrix of measure. Although I do not favor the idea, there are actually still some who choose FCR and do quite well.

Generally speaking though, Acalabrutinb is showing a more favorable side affect profile than Ibrutinib especially with Afib.

Keep in mind that our perspectives on why one drug is better than the other is not a measure for approval by FDA. They sometimes approve or disapprove making no sense to me. There is a lot going on behind the scenes with approving a drug, including another drug under study that is not previewed to the public.

[may04cll in reply to Smakwater]

The cost of acalabrutinb will be so out of range for many here in the states

[Zweistein in reply to may04cll]

Here in Germany the price difference is less than 10%. (5 800€ vs 6 200€). It is Pirtobrutinib that costs about twice as much. I do not know if the insurance companies have special conditions.

[BigfootT]

My understanding from a conversation I had while at an appointment at NIH. During the early trial of the I+V combo they had some patients entered in the US who had pre-existing heart conditions. A few of those patients had sudden death and the trial was stopped. The doctor said the FDA sort of boxed itself in a corner. He felt A+V was likely to be approved in 2025. Bigfoot

[Skyshark in reply to BigfootT]

GLOW trial. Oddly most of them seem to have been IgHV unmutated (u-CLL). 10 "events" for u-CLL while on treatment against 2 for m-CLL (also 2 censored at 0.1 years). I believe there were 7 heart related deaths.

FDA will allow removing COVID deaths but not the treatment related heart ones. Europe, Australia and Canada have approved V+I.

"events" are progression or death, "censored" means the subject has either been on the trial that long or left the trial. I'm not sure if RT counts as a progression or is just censored.

CLL14 V+O short duration trial had no treatment related "events" during treatment.

I was offered "tablets forever" before having the ECOG. Don't know what they would have done or said if I had chosen "tablets forever" and the ECOG result was bad or even if they would have done the ECOG.