Pirtobrutinib

[Stewie_1968]

Hi I know it's not been approved by NICE in the UK but is Pirtobrutinib being used for CLL in the UK off label so to speak

Regards

Stewie

[Skyshark]

Trial of Pirtobrutinib (LOXO-305) Plus Venetoclax and Rituximab (PVR) V's VR. Obviously no use if refractory to Venetoclax.

bepartofresearch.nihr.ac.uk...

It's in some (well at least one) hospitals formularies. Such as this one for NUH - Nottingham University Hospital. It maybe limited to a few hospitals, these could be major hospitals within each cancer alliance such as ones that do stem cell transplants. If your doctor doesn't know how to access it and you meet the use criteria, then you need to request transfer to a specialist that does - it's down to them to find that specialist. I believe it was approved at "RED" 2022.12.07.

nottinghamshireformulary.nh...

Unlicensed Tablets (50mg and 100mg)

NUH only:

Approved in accordance with the compassionate use scheme:

Monotherapy for previously treated CLL, relapsed after 3 or more lines of therapy that contain BTK inhibitors (ibrutinib/acalabrutinib) and BLC2 inhibitor containing regimens (Venetoclax)

[Nicebaps]

As per the previous comment. Available under compassionate grounds direct from the manufacturer. I was on Pirtobrutinib 2023/2024 mono which was effective for about 10 months.

[UKfulloflife]

As far as I'm aware, it's still at the clinical trial stage in the UK and is not available outside of this. I've been on it for coming up to 5 years now. Whenever I've asked if I would still be able to have it when the trial stops, I've been told that the manufacturers would be morally obligated to allow me to continue for as long as it keeps working. At my last appointment with my research nurse she seemed to think that the trial was going to be 'rolled forward. Absolutely no idea what that means!!!

Just read the above comments - def a step in the right diretion!

[bennevisplace in reply to UKfulloflife]

...the trial was going to be 'rolled forward' indicates the trial is likely to be prolonged to a new end date.

[UKfulloflife in reply to UKfulloflife]

Thanks!!

[Stewie_1968 in reply to UKfulloflife]

Didn't realise they being used for that amount of time , is that a single agent just Pirtobrutinib ?

[UKfulloflife in reply to Stewie_1968]

Yes, just Pirtobrutinib. I was one of the first patients on the clinical trial at my hospital (Churchill in Oxford) - it was called Loxo 305 then, and is still referred to as this when I pick up my pills from the pharmacy. Originally I signed up for a 3 year trial, but the goal posts keep moving. It has quite literally saved my life - seriously that is no exaggeration!

[Jm954 Administrator]

NICE ID 6269 - the Pirtobrutinib appraisal was meant to be 2024 but will now begin during mid-April 2025 when they will write about how stakeholders can get involved. The deadline for submissions is expected in approximately late June 2025. The scope is Pirtobrutinib for treating chronic lymphocytic leukaemia or small lymphocytic lymphoma after 1 or more BTK inhibitors.

It's available in trials as others have said, generally for patients who have failed both BTK and BCL2 inhibitors.

Jackie