Revisiting Ibrutinib , but then no Venetoclax?

[Me2AsWell]

I am a decade into the CLL journey with non mutated 11q deletion - woohoo! I went through FCR in 2014 and am now relapsing, so gearing up for the next round ...

As I noted a couple of months ago here in the UK, I was told that if that:

1. if I start with Ibrutinib s my second line treatment, I cannot go to Venetoclax-Rituximab in the event that I have to quit Ibrutinib ... I would just get Venetoclax alone (no Rituximab) as this is recommended as the third line; whereas

2. if I take Venetoclax-Rituximab as a second line treatment and need to change, I can then go to Ibrutinib.

This seems strange ... has anyone else been told this? Or know the underlying (cash or science) logic?

[cajunjeff]

This all probably relates to what situations the drugs have approval for which in turn is a function of the clinical trials.

Typically very new drugs, which are untested and therefore more risky, are first tested in clinical trials with patients who have been through several therapies and have few other options. So if a venetoclax/rituximab combination did well in a trial with people who had prior therapies, it would be approved not front line but rather in the same scenario as the trial design, only for people with prior therapies.

Now a doctor and others might well conclude that this combination work work well front line and in other sequences, but its actually only been proven to work second line because thats how the trial tested it.

Ventoclax is being tested in all kinds of trials and combinations now, so we will likely see much broader approvals down the line.

Doctors are not bound by approvals and, depending on where you live, can prescribe venetoclax and other drugs outside of their approved use. Then you could have insurance issue though, as some insurance polices and national health care plans only cover approved uses.

Approved uses appear on the label of a drug. When a doctor prescribes a drug for a use not on the label, it is called off-label use. My doctor is considering adding venetoclax to my ibrutinib. While that is not yet an approved use, there is every reason to believe it will be soon based on how well that combination is doing in trials now.

[bkoffman CLL CURE Hero in reply to cajunjeff]

Perfect explanation and fully applicable in the USA. UK drug use is more circumscribed by the government.

[cllady01 Former Volunteer]

Note: cajunjeff is in US and you are in UK. While his statements are true for U.S. it is a different system altogether. Just saying, the protocol may be stricter as far as subsequent medications as well a the uses may be more strictly observed as NHS is footing the bills.