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End of AMN 107 trial

Hi everyone,
I have just been told by the hospital that the trial I am on (amn 107/Tasigna) finishes on June 15th. This is not what I was told when I started on the trial in Jan this year. It seems that as the drug has been commercially launched this week Novartis has brought the trial to an end.

So here we go again with letters to PCT's etc. Lobbying and letters to MPs and others.

I must say that i feel let down that this has happened so suddenly, and that yet again as a patient I find myself caught in the cross fire between drug company, hospital and PCT's for funding.

It seems from what I have managed to find out this morning that the drug will still be available to trial patients for some time via the hospital, but no timescale is available.

Wow what a blow, I know we need drug companies but this is not very good public relations.

Plus I have agreed to talk about the drug in a radio interview today set up by Novartis !

ATB
Pennie.

Hi Pennie,
I understood that the ENACT trials were to end at some point after April. What were you told by your hospital?
As far as I understand most clincal trials end when the drug is launched... as you have confirmed in your post.

I contacted Novartis some months ago and asked what the situation would be for trial patients once the trials closed.
The information I was given then was that in the UK, ENACT trial patients will continue to receive the drug from Novarits for at least 12 months after the trials close. As I say this was some months ago but I assume that Novartis (by their past record) will continue to provide access until nilotinib is available on the NHS.... Given the fact that nilotinib and dasatinib are currently waiting to go into NICE system for approval, and the time frame for that could be up to 15-16 months from now before we have a decision, there may well be a gap of some 2-3 months.
I assume Novartis will expect to cover patients who are currently on the drug and live within PCT areas that are reluctant to fund.
As you are treated at Kings I cannot see that there will be a problem in you receiving the drug. As you say in your post you have been told that you will continue to receive the drug via the hospital... who in turn will receive it for trial patients from Novartis for the next 12 months at least.

Are you worried because you have not been given a firm time frame? I am sure all will be well Pennie and there is no need to worry. If you are giving an interview as a nilotinib patient then it might be a good opportunity for you to ask the representatives of Novartis for an outline of their plans to cover trial patients should they find their therapy suddenly withdrawn.

I hope you are continuing to respond well to nilotinib.
best wishes,
Sandy

Pennie: The procedure for the continuing supply of drugs for the participants of the trial should be enshrined in the Protocol document. In the case of Trial 106 (the trial where STI 571 was tested against interferon in newly diagnosed patients)the document clearly stated that when the trial ended the patients would continue to receive the drug provided it was doing them good. Actually, the trial was extended and is still current.

There was an attempt to put the burden on the PCT when the trial was due to finish but this brought response from outraged patients who insisted that the drugs should be continued to be supplied by the trial promoter, Novartis, as per the protocol document. Trial 106 is unusual in that it did not end when STI 571 was launched as Glivec/Gleevec. So check with the protocol document first to see what was promised and insist that the promise will be honoured. Peter Capel