Is anyone aware of Expanded Access or Early Access Program?

[hopeforcancer]

Is anyone aware of expanded access or early access program for dabrafenib/trametinib? What alternatives do patients who are waiting for combination therapy have?

[Catherine Poole]

These drugs have been approved in the US, UK and Europe.

[AndyT]

My friend in the pharma business told me that even though dabrafenib/trametinib is approved in EU, it may take a while (some months) until they actually “hit” the shelves. In the meantime as far as I know there are good chances that you get the medication on a compasionate use basis, it could be faster. As far as I know (please other form users correct me if I am wrong), the oncologists have to apply for compasionate use to the pharma company, there is some involment of the ethics commission, but once this is approved they can get it rather quickly – especially in cases where medication is close to approval/actual use, which is the case with dabrafenib/trametinib.

[Catherine Poole]

Here is what I found out: There’s a compassionate scheme in Europe (because it may be as you said Andy, another year to hit the shelves) that the patient’s treating doctor has to approach GSK via their medical team to access. Also certain criteria have to be met to be eligible for the scheme.

Only dabrafenib is approved at this stage in the EU we are still waiting for the EMA to approve tremetinib. Both are approved in the U.S.

[Sara]

Does anyone know if they have granted compassionate use of a Mek or Braf or combo inhibitor to someone who has already had Both a Mek and a Braf inhibitor, but under a re- challenge situation?

[NYKaren]

Hi Sara,

I progressed with brain mets after 6 months on Zelbarof.

I am in the US, and my mail-order pharmacy has sent me two deliveries of Tanlifar.

Someone in my doctors’ office said “are these pharmacies really that dumb”?

It scares me that they’re going to catch on!

Karen

[Author]

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