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snoopy 10-03-2005 07:36 AM

Herceptin Availabilty
 
I've been reading that Herceptin has been fast tracked for use in primary BC in a number of countries (US, Canada, France, Germany, Netherlands - ?? there may be more).

Does anyone have any links/references to "official" documents stating what the situation is in their country??? (had a look on the FDA website but couldn't find anything).

Thanks

Christine MH-UK 10-03-2005 11:47 AM

Hi Snoopy,
I have heard that Roche isn't going to submit the licensing paperwork in Europe until early 2000. Apparently the results have to be published in a peer-reviewed journal first, but the New England Journal of Medicine is expected to do this first.

However, it is important not to confused licensing with availability, since oncologists can often use drugs for non-licensed indications. And even when drugs have been licensed, there are still issues of availability in some countries.

Take care,
Christine

JohnL 10-04-2005 09:19 AM

Justice done in UK
 
In the UK the National Health Service has been ducking the herceptin issue for primary and early bc by arguing that 'Roche has not applied for a licence yet, who's to know if it is safe?'

Nonsense, naturally, but just for once a high court judge has applied a bit of common sense and enforced a patients right to be prescribed herceptin if the circumstances make it a sensible course of action.

http://www.telegraph.co.uk/news/main...04/ixhome.html

A man wearing a wig, red dressing gown and silk stockings has just kicked open the floodgates.


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