Waiting for Pirtobrutinib

[KLWC]

My husband has been on venetoclax for 3 years and a recent bone marrow biopsy shows cancer is growing and is up to 60%. His oncologist wants to put him on Pirtobrutinib, but it isn’t available yet. Does anyone know we can gain early access to this drug? He is 76 , diagnosed 13 years ago. He was in Ibrutinib prior for 3 years until it stopped working. He had traditional chemotherapy and a watch and wait period of a year but relapsed with 6 eeeks.

[Justasheet1]

Kl,

A clinical trial would be the easiest way in my opinion. Can you get to a CLL center?

Your doctor should be doing the legwork for you.

Jeff

[cllady01 Former Volunteer]

KLWC, it would be helpful to know where you live. Access is not the same in every country.

[KLWC in reply to cllady01]

We live in the Atlanta area. There was a clinical trial at Emory where his oncologist is but at the time he was still on venetoclax. While awaiting FDA approval Pirtobrutinib, they have prescribed Copiktra (Duvelisib), but said it is only about 40% effective and has very harsh side effects.

[cllady01 Former Volunteer in reply to KLWC]

clinicaltrials.gov/ct2/show...

"The above research study suggests "you or your doctor may contact the study research staff using the contact information provided by the sponsor"

Please refer to the study by its ClinicalTrials.gov identifier (NCT number): NCT03740529

Contact: Patient Advocacy 1-855-LOXO-305 [e-mail]

[KLWC]

Anyone on Copiktra (Duvelisib)? This is being prescribed as an interim while my husband waits for FDA approval for Pirtobrutinib,

[Agiledog]

Would this perhaps be an option? NCT05172700 This trial has an “expanded access” to pirtobrutinib for those previously treated folks who are ineligible for the trial itself. This is based on your physician’s referral. Perhaps you’re already aware of it. Best of luck.

[KLWC in reply to Agiledog]

Thanks for your reply. We contacted Loxo Oncology directly. They informed us about a pirtoimbrutinib trial however his oncologist did not like the other two arms that he might be randomized into. Actually he has already been on Bendamustine/Rituxan which is one arm and was just informed that that the Idelalisib/Rituxan isn’t working. Although Rituxin wasn’t part of it.

[Agiledog in reply to KLWC]

Sounds like you are with an amply sharp oncologist who follows the literature closely. Very best wishes to you guys. Bud

[KLWC in reply to Agiledog]

Thank you!