Nivolumab (Opdivo) from BMS has just been approved for Melanoma

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NanoSecond
NanoSecond Member Posts: 653

What a wonderful Christmas present for all of us!

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm427716.htm

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  • sblairc
    sblairc Member Posts: 585 Member
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    Big news for many Kidney cancer patients, even though Melonoma

    I'll admit, I cried a little. This is huge. 

  • foxhd
    foxhd Member Posts: 3,181 Member
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    sblairc said:

    Big news for many Kidney cancer patients, even though Melonoma

    I'll admit, I cried a little. This is huge. 

    Victory

    What a victory! So many will be helped. I was lucky to have been given the chance to prove it's effectiveness in trial. It is going to help many people.

  • Jojo61
    Jojo61 Member Posts: 1,309 Member
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    foxhd said:

    Victory

    What a victory! So many will be helped. I was lucky to have been given the chance to prove it's effectiveness in trial. It is going to help many people.

    That is great news!
     

    That is great news!

     

  • foroughsh
    foroughsh Member Posts: 779 Member
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    question

    every one is happy so congratulations, I don't know about Nivolumab, could someone please tell me about it? and is it now approved only in US or can we have access to it all over the world?

  • vinnyc
    vinnyc Member Posts: 19
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    foroughsh said:

    question

    every one is happy so congratulations, I don't know about Nivolumab, could someone please tell me about it? and is it now approved only in US or can we have access to it all over the world?

    Nivolumab

    BMS PD-1 (nivolumab) (Opdivo) read the posts. It's the same drug. All over the world? Where do you live? Melanoma only in the US. Read the previous posts, it's all there. Google it.

     

  • vinnyc
    vinnyc Member Posts: 19
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    Meteor trial

     

    Phase 3 BMS PD-1 (nivolumab) (Opdivo) vs Affinitor Everolimus has started. Correct me if I'm wrong. Once preliminary data comes in and if it's very positive in the favor of PD-1, BMS could apply to the FDA for RCC approval, because the drug has breakthrough status. That's what they did for melanoma. I think that is how it's going to happen.

  • NanoSecond
    NanoSecond Member Posts: 653
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    foroughsh said:

    question

    every one is happy so congratulations, I don't know about Nivolumab, could someone please tell me about it? and is it now approved only in US or can we have access to it all over the world?

    FDA Approval

    FDA approval applies to the USA only. 

    However, Nivolumab has already been approved (I believe for RCC no less) in Japan.  I am not aware of anywhere else.

  • foxhd
    foxhd Member Posts: 3,181 Member
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    FDA Approval

    FDA approval applies to the USA only. 

    However, Nivolumab has already been approved (I believe for RCC no less) in Japan.  I am not aware of anywhere else.

    easy to take

    ..and what I found to be amazing was just how easy it was to take. Once I saw my doctor and she decided the days infusion was a go, they would make it up right there in the sink. It would take 2-3 hours to brew, and an hour to be dripped into my plumbing. Only once did I think  I might vomit. But that could have been anything. So it accounted for one infusion every three weeks. Unfortunately, once I kissed a cop down on 34th and vine, he broke my little bottle of health potion #9.

    I remember being a bit afraid. At that point, I had had my nephrectomy but no other treatments. Only  a few of us had recieved nivolumab, and how we tolerated it was to be seen. I had been on 10mg/kg of body weight. That was the highest dose available. The lowest dose for some may have been as low as .5mg/kg body weight. There were no issues what so ever. Maybe a little fatigue. It was hard to determine. Certainly no big deal. I am sure that I will need some additional treatments of something someday soon. If and when that day comes, I pray that I can benefit from nivolumab again. I love to imagine that I have a long natural life to live. Being treated for metastatic kidney cancer will be no problem at all. NED would be ideal. But no longer necessary.