Ibrutinib (Imbruvica) is Approved for CLL
No matter who we are or where we are in our lives with CLL, today is a great day.
Ibrutinib was approved as mono-therapy for CLL patients who have had at least one prior therapy.
That is a very broad indication and that's good.
What that means is that the majority of us who might benefit from ibrutinib because we need treatment for CLL for a second time can now get it outside of a clinical trial.
The obvious folks left out with this present indication are those with high risk treatment naive CLL such as those with 17p deletion who need front line therapy now.
Will it be used off label?
It already is. Patients have been getting it for CLL already before this approval.
Will it be used in combinations with chemo and mAbs (monoclonal antibodies)?
I am sure it will be. Lots of trials addressing this.
Will it be used up front for those with 17p deletion.
I sure hope so. These too has been and is being studied.
There are several stage three trials ongoing to address all these issues and more. This accelerated approval is just the first step, but it is a giant step. I am sure the indications and labeling will change and broaden as more data is collected and we learn more. The FDA is very conservative and not very speculative.
But from today forward, those of us in the USA facing the need for therapy for our CLL, ibrutinib has just become a real possibility, and probably a near certainty if we had at least one prior therapy. That is a pretty low bar to jump over.
And at least for those of us not on Medicare, the support to help patients afford the medication from Pharmacyclics is strong.
For those of us already in ibrutinib trials (especially continuation trials such as the one I am in), I am not sure what this will mean. Will our bodies and our blood still be wanted? Time will tell and I suspect some but not all trials will be terminated.
For those outside the USA, this is a positive step, but hardly a guarantee that Imbruvica will soon be a pharmacy near you. Politics and budgets are different in every country, and that is why we need active and informed patients and providers to advocate for our best choices
Still this is a day to celebrate. Time for victory dance.
Here is the official press release from Pharmacyclics.
Ibrutinib was approved as mono-therapy for CLL patients who have had at least one prior therapy.
That is a very broad indication and that's good.
What that means is that the majority of us who might benefit from ibrutinib because we need treatment for CLL for a second time can now get it outside of a clinical trial.
The obvious folks left out with this present indication are those with high risk treatment naive CLL such as those with 17p deletion who need front line therapy now.
Will it be used off label?
It already is. Patients have been getting it for CLL already before this approval.
Will it be used in combinations with chemo and mAbs (monoclonal antibodies)?
I am sure it will be. Lots of trials addressing this.
Will it be used up front for those with 17p deletion.
I sure hope so. These too has been and is being studied.
There are several stage three trials ongoing to address all these issues and more. This accelerated approval is just the first step, but it is a giant step. I am sure the indications and labeling will change and broaden as more data is collected and we learn more. The FDA is very conservative and not very speculative.
But from today forward, those of us in the USA facing the need for therapy for our CLL, ibrutinib has just become a real possibility, and probably a near certainty if we had at least one prior therapy. That is a pretty low bar to jump over.
And at least for those of us not on Medicare, the support to help patients afford the medication from Pharmacyclics is strong.
For those of us already in ibrutinib trials (especially continuation trials such as the one I am in), I am not sure what this will mean. Will our bodies and our blood still be wanted? Time will tell and I suspect some but not all trials will be terminated.
For those outside the USA, this is a positive step, but hardly a guarantee that Imbruvica will soon be a pharmacy near you. Politics and budgets are different in every country, and that is why we need active and informed patients and providers to advocate for our best choices
Still this is a day to celebrate. Time for victory dance.
Here is the official press release from Pharmacyclics.
Labels: Chronic lymphocytic leukemia, CLL, FDA approval, ibrutinib, Imbruvica
posted by Brian Koffman at
4:56 PM
3 Comments:
Amen!!! Oh happy day!!!
Happy dance time!! When I was diagnosed in 2006, this possibility seemed far away and not certain. I am grateful to know that this and others like it will be waiting for me when it's time for my second treatment.
I cannot imagine that patients currently having a good response will not have a continuation trial. PCYC needs long term data, especially given their accelerated approval. (BEXXAR got it but then had trouble with the long term data, making their case to the FDA). So I am assuming those on the drug via trials, especially those on Medicare Part D, will continue to get the drug. It would be criminal if that weren't the case as not too many people have been studied having gone off the drug, as well I know. Hope that all who want this drug will have access to it. And thanks to all who did trials, especially the Phase I trials before we all knew how great it was.
Lynn S.
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