Nivolumab (Opdivo) from BMS has just been approved for Melanoma
What a wonderful Christmas present for all of us!
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm427716.htm
Comments
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Victorysblairc said:Big news for many Kidney cancer patients, even though Melonoma
I'll admit, I cried a little. This is huge.
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.
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Nivolumabforoughsh 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?
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.
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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.
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FDA Approvalforoughsh 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 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.
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easy to takeNanoSecond said: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.
..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.
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