Just putting some feelers out there. Has anyone experienced Pirtobrutinib (BTKi) other than in a trial and if so how successful was/is it. I would be interested to know of any side effects, if any. Just started this treatment in the past week so would appreciate any feedback.
Thank you
I didn’t know it was approved if one isn’t in a trial. I’m hoping it’s my next try.
It's only available in a trial or by compassion use. Not approved in the US.
Dr. Hoffman, do you know when pirtobrutinib will be approved for CLL in the US? I am failing my 4th treatment, calquence.
I expect you'll see an update in the CLL Society's news (Dr Koffman and his wife founded CLL Society). There was a recent update here: cllsociety.org/2023/07/pirt...
which we similarly covered healthunlocked.com/cllsuppo...
Meanwhile, look for clinical trial opportunities, as mentioned here: healthunlocked.com/cllsuppo...
and as mentioned earlier in this post here healthunlocked.com/cllsuppo...
Neil
No one knows for sure what and when the FDA will do, but they did just grant priority review so hopefully it will be approved before year's end. Moreover, since it is now part of the NCCN guidelines, it is very easy to get "off label".
My oncologist told me unless FDA approved I wouldn’t get payment assistance from PAN foundation. She said its either pirto or a clinical trial. I would prefer pirto, but would need payment assistance, so I guess I have to wait.
Pirtobrutinib (LOXO-305) is a third generation non-covalent bonding BTK inhibitor. As Dr Koffman says, "It's only available in a trial or by compassion use." I'm not aware of it being approved anywhere. When it is approved, it will be huge news, because most people who become resistant to any of the covalent bonding BTKi drugs, which currently is limited to Acalabrutinib and ibrutinib (and off label Zanubrutinib), could switch to pirtobrutinib and stay on a BTKi drug for perhaps another 5 to 10 years before needing to switch to another class of drug.
Why is this huge news? It's because the approval of any non-covalent BTKi significantly reduces the gap in life expectancy towards a normal life expectancy.
Nicebaps, how did you manage to obtain access to pirtobrutinib in the UK? It's great news for you personally, for the reasons obvious from reading your updated bio and encouraging news for all of us. Wishing you every success. Please let us know how you go.
Neil
Great news for many. I’m hoping I can handle it.
As far I as am aware, Pirtobrutinib is still only available on the global trial, which is ongoing. I guess,Nicebaps, you are a part of one the UK trial groups??
Thank you for your replies. I've started Pirtobrutinib under Compassionate grounds in the UK.
I will be stating pirtobrutinib soon under compassionate care. Can you share about your experience since in it fir a few months?
All the best Nicebabs.
You seem to have had a difficult time with a series of unsuccessful treatments. I really hope Pirtobrutinib proves more effective, all the evidence so far is good. Many of us, while wishing you well, will be very interested how it goes.
Roger
Thank you Roger. I'll keep you updated.
Hi Nicebaps & responders,
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I was able to find this clinicaltrials.gov/ct2/show...
This is an expanded access program for eligible participants with a previously treated B-cell cancer who are ineligible for an ongoing pirtobrutinib clinical trial.
The treating physician/investigator contacts Lilly when, based on their medical opinion, a patient meets the criteria for inclusion in the expanded access program.
Contact: In the U.S., physicians seeking help on behalf of their patients may contact Lilly at 1-800-LillyRx (1-800-545-5979) Clinicaltrials.gov@lilly.com
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Len
I was on LOXO 305 for 19 cycles before it stopped working for me. I had become resistant to ibrutinib and venetoclax previously. LOXO was the best CLL drug I have been on. I had no side effects and frankly did not know it was on board. Good luck and I hope it works as well for you. Tony
May I adk, what treatment you went on after Pirtobrutinib. I will be starting the drug soon. I heard the it is effective up to 2 years. Pirto will ne my 5th treatment. Doc sats clinical trial after this.
I went on LP-168 and them MS -553. Neither worked well for me. I had the first Obinatuzamab injection over 2 days and ended up on the hospital for a week with neutropenic fever. It has taken the 4 months for my counts to recover. My hemoglobin is finally at 10 and platelets 36. I was on blood and platelet transfusions for months. I am currently on pirtobrutinib and venetoclax and they are working well despite having failed both drugs previously. I am awaiting another study as my counts improve more.
I am so glad to hear the drug combo is helping you!
Thank you Cycle
Wow, you have been through so much. My thoughts and prayers are with you for success.
Hope you are well. How is Pirtobrutinib working for you?
Hard to tell really. Just about to start me 4th cycle. No side effects to speak of. The only thing I've noticed is that my WBC is slowly rising. Mentioned it to my Haemotologist and she's not that concerned.
How are you?
Disease Progression on Pirtobrutinib
Waiting for Pirtobrutinib
Finishing line for Pirtobrutinib (Loxo) & Venetoclax combination trial.
