Accessing anti-PD1 therapy in europe

[JBunyan]

I had Ipi, and so far have total remission. (In UK). I believe the success rate is about 30%. Ipi + PD1 I believe is said to be better than 50% but is only available as part of trials at present. I am puzzled about talk of BRAF – I am BRAF wild type, which I do not see mentioned here – BRAF with mutations seems to be widely discussed. What does “BRAF positive” mean – and is wild type included?

[Catherine Poole]

No, wild type is not considered BRAf positive. You may be NRAS positive which could open up other studies for you!

[Silkroad]

Hi,

I am in a similar situation. My mom was diagnosed with stage IV mucosal melanoma in May with metastatic tumors in her spinal canal. So she cannot walk now. We are in China and I work in the US. Does anyone know whether they accept international patients at all? If not, has anyone tried to purchase the drug in Japan? Thank you very much and I really appreciate your kind help.

Rong

[Catherine Poole]

Yes, many of the Expanded Access programs are accepting patients in the U.S. from other countries. Where do you live? I don’t know the process in Japan at all. I will see what I can find out though.

[Silkroad]

Hi, Catherine,

Thank you so much! We are in China now. My mom has never had the ipi treatment. Will this make her not eligible for the trials? Thank you.

Rong

[Silkroad]

Hi Catherine,

I got the email back from the BMS EAP program and they asked my mom’s doctor to send the request through the EAP link. For Nivo, they have the following locations.

nivolumab (BMS-936558) *Melanoma Named Patient (Australia, Israel, Mexico, New Zealand, South Africa, Turkey, Venezuela)

nivolumab (BMS-936558) *Melanoma (US, Canada, Argentina, Brazil, Chile, Colombia, Peru)

Unfortunately, China is not among the list. Does this mean my mom won’t be able to get the medicine? How about the Merck EAP program mentioned in another post? Thank you very much.

Best,

Rong

[Gilly]

Bonjour,

Mon mari est patient stade 4 a l’IGR – ils ont l’anti PD1 de Merck et l’essai de Nivo (l’anti PD1 de BMS) – mais je crois que l’essaie Nivo est deja remplie. Caroline Robert est tres forte en Melanome – mais il y a aussi J-J Grob a Marseille et Dr Mortier a Lille – pour l’anti PD1 de Merck il faut avoir eu l’Ipilimumab – Bravo pour votre soin de votre patiente ! C’est assez rare parmi des medecins traitant d’avoir ceci !

Gilly

[Gilly]

As for the question re Japan – I thought the japanese had approved the Nivo Anti PD1 under their pharma ONO ??

http://www.fiercebiotech.com/story/anti-pd-1-cancer-star-nivolumab-wins-worlds-first-regulatory-approval/2014-07-07

[Catherine Poole]

Rong,

You will have to get your doctor to inquire about the Merck EAP, they are not fully disclosing global locations for regulatory reasons. It will be approved for prescription in the U.S. in October.

[rick1981]

Hi Gilly,

Do I understand you correctly that in Paris they have access to both Pembrolizumab (Merck PD1) and Nivolumab (MBS PD1)? And which do they recommend?

Thanks, Rick

[Silkroad]

Hi，Catherine,

Thank you very much for the information. I will ask the doctor. So he needs to ask the Merck representative? Thanks.

Best,

Rong

[Gilly]

BMS has told me that they are not taking any new patients in France onto Nivo trials but the Merck expanded access is available if you fulfil the protocol criteria.

[hass71]

is there any access to anti-pd1 in Arab countries or in turkey?

[EvaSara]

From what I understand, the respective drug companies have applied to the European Medicines Agency for approval of Keytruda (Pembrolizumab/MK-3475) and Opdivo (Nivolumab). The decision for Keytruda is expected between April-June 2015 and the decision for Opdivo might take a couple of months longer.

Also from my understanding, the applications are based on clinical trials where the drugs have been used as second or third line therapy after Ipi and BRAF inhibitor. I think that this means that they can only be approved as second or third line therapy.

Is that correct? Does anyone have any more information about this? Can the drug companies supply more data during the application process from clinical trials where the drug has been used as first line therapy and compared to Ipi? Or would that require a new and separate application?

Also, are there any new clinical trials coming up with PD-1 as first line therapy?

I have second hand information from a doctor in Sweden that PD-1 should be first line therapy but that is NOT consistent with any public information that I can find.

[Catherine Poole]

Hass: I would check in Israel:

Ella Institute

Sheba Medical Center

Tel Hashomer

52621 Israel

+972 3 530 2555

http://www.eng.sheba.co.il

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