Home Forums Melanoma Diagnosis: Stage IV Accessing anti-PD1 therapy in europe

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  • #65080
    JBunyan
    Participant

    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?

    #65081
    Catherine Poole
    Keymaster

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

    #65082
    Silkroad
    Participant

    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

    #65083
    Catherine Poole
    Keymaster

    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.

    #65084
    Silkroad
    Participant

    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

    #65085
    Silkroad
    Participant

    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

    #65086
    Gilly
    Participant

    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

    #65087
    Gilly
    Participant

    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

    #65088
    Catherine Poole
    Keymaster

    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.

    #65089
    rick1981
    Participant

    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

    #65090
    Silkroad
    Participant

    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

    #65091
    Gilly
    Participant

    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.

    #65092
    hass71
    Participant

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

    #65093
    EvaSara
    Participant

    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.

    #65094
    Catherine Poole
    Keymaster

    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

Viewing 15 posts - 16 through 30 (of 36 total)
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