› Forums › General Melanoma Community › Merck scores “breakthrough status” from FDA
- This topic has 12 replies, 4 voices, and was last updated 12 years ago by
LynnLuc.
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- April 24, 2013 at 5:34 pm
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- April 24, 2013 at 11:43 pm
Sounds exciting!
Does anyone know what this translates to regarding approval time?
Karen
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- April 25, 2013 at 12:36 am
While this is certainly not bad news at all….I fear the reality of this is more of an ad/announcement for Merck seeking financial investors than it is for medical providers or patients. Just google "lambrolizumab" – the "name" that Merck has given its anti-PD1 product and you will see that this news is almost exclusively spread in financial/investor journals and articles. That said, it is still good news for it getting ever closer to FDA approval. And….given my review of the data….preliminary though it is….and through discussions with my provider…(though Merck's still running behind BMS in data accumulated)….it is looking as though the Merck results might be better than the BMS anti-PD1 that I am taking. SO….it is still wait and see for those in desperate need of both these therapies. I think the data to be presented at ASCO in June will be very informative and crucial in getting these drugs approved and on the market.
Hang in there. C
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- April 25, 2013 at 12:36 am
While this is certainly not bad news at all….I fear the reality of this is more of an ad/announcement for Merck seeking financial investors than it is for medical providers or patients. Just google "lambrolizumab" – the "name" that Merck has given its anti-PD1 product and you will see that this news is almost exclusively spread in financial/investor journals and articles. That said, it is still good news for it getting ever closer to FDA approval. And….given my review of the data….preliminary though it is….and through discussions with my provider…(though Merck's still running behind BMS in data accumulated)….it is looking as though the Merck results might be better than the BMS anti-PD1 that I am taking. SO….it is still wait and see for those in desperate need of both these therapies. I think the data to be presented at ASCO in June will be very informative and crucial in getting these drugs approved and on the market.
Hang in there. C
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- April 25, 2013 at 12:36 am
While this is certainly not bad news at all….I fear the reality of this is more of an ad/announcement for Merck seeking financial investors than it is for medical providers or patients. Just google "lambrolizumab" – the "name" that Merck has given its anti-PD1 product and you will see that this news is almost exclusively spread in financial/investor journals and articles. That said, it is still good news for it getting ever closer to FDA approval. And….given my review of the data….preliminary though it is….and through discussions with my provider…(though Merck's still running behind BMS in data accumulated)….it is looking as though the Merck results might be better than the BMS anti-PD1 that I am taking. SO….it is still wait and see for those in desperate need of both these therapies. I think the data to be presented at ASCO in June will be very informative and crucial in getting these drugs approved and on the market.
Hang in there. C
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- April 25, 2013 at 6:45 am
It's a great day in melanomaville! I've been on MK3475 for a year now and have had awesome results. I'm happy for Merck that they use this opportunity to seek investors, private enterprise at it's best rather than waiting for government. As far as approval time, this announcement will help drive people to the trials, they fill faster, more research is completed and faster approval is the result. My Doc believes approval will be within 2 years and more trials are opening regularly.
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- April 25, 2013 at 6:45 am
It's a great day in melanomaville! I've been on MK3475 for a year now and have had awesome results. I'm happy for Merck that they use this opportunity to seek investors, private enterprise at it's best rather than waiting for government. As far as approval time, this announcement will help drive people to the trials, they fill faster, more research is completed and faster approval is the result. My Doc believes approval will be within 2 years and more trials are opening regularly.
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- April 25, 2013 at 6:45 am
It's a great day in melanomaville! I've been on MK3475 for a year now and have had awesome results. I'm happy for Merck that they use this opportunity to seek investors, private enterprise at it's best rather than waiting for government. As far as approval time, this announcement will help drive people to the trials, they fill faster, more research is completed and faster approval is the result. My Doc believes approval will be within 2 years and more trials are opening regularly.
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