Promising results for new drug
http://www.medpagetoday.com/Gastroenterology/ColonCancer/29286
There is always hope...
Hugs,
Sara
Comments
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The studycoloCan said:Some in this trial had been receiving a placebo
but due to positive results thus far, they can now receive the drug being tested, for mCRC....A little more info at:medscape.com/viewarticle/752288
was placebo controlled, along with best standard of care. The difference in survival was apparently dramatic enough to move the remaining placebo group over to the new drug early.
This would be for patients who have exhausted all other treatments.
Of course we will not know what passed for best standard of care, or what the relative stats were until the study is published.0 -
How long can it takes to be approved by FDA?Liz2011 said:Thank you!
This means a little hope for my mum! Need to find out more and see whether she can get some in France fairly soon... I will leave no stone unturned!
Liz
Do they say anything about when is going to be in the market?
Hugs!0 -
It is a fastrack drugpepebcn said:How long can it takes to be approved by FDA?
Do they say anything about when is going to be in the market?
Hugs!
Which has now passed the phase 3 trial. Depending on other factors, this could come to market in one to two years, possibly less.
How about in the EU market? Do you have any thoughts on what the approval process is like? From what I have read recently, the FDA has a better record of getting drugs like this to the public quickly than the European regulatory agencies.0 -
Try this web address
http://www.prnewswire.com/news-releases/phase-iii-trial-of-bayers-investigational-compound-regorafenib-bay-73-4506-in-metastatic-colorectal-cancer-meets-primary-endpoint-of-improving-overall-survival-132598533.html
sorry about double post don't know what happened........0 -
Take the money and runcoloCan said:Some in this trial had been receiving a placebo
but due to positive results thus far, they can now receive the drug being tested, for mCRC....A little more info at:medscape.com/viewarticle/752288
Also short tests are often more favorable to new drugs with either long term side effects or less favorable overall survival impact, like Avastin in breast cancer or stage III colon cancer.
Any quarter focused manager is going to take the first favorable result accepted by the FDA and run. It starts the cash flow sooner, minimizes capital exposure and maximizes revenue. Once accepted, it is harder for the FDA to backtrack on cancer drugs.0 -
As per I have seen EMEA is always a little bit late than FDA.Buckwirth said:It is a fastrack drug
Which has now passed the phase 3 trial. Depending on other factors, this could come to market in one to two years, possibly less.
How about in the EU market? Do you have any thoughts on what the approval process is like? From what I have read recently, the FDA has a better record of getting drugs like this to the public quickly than the European regulatory agencies.
Hugs Buck.0 -
Thks cinnamon!cinnamongirl56 said:Try this web address
http://www.prnewswire.com/news-releases/phase-iii-trial-of-bayers-investigational-compound-regorafenib-bay-73-4506-in-metastatic-colorectal-cancer-meets-primary-endpoint-of-improving-overall-survival-132598533.html
sorry about double post don't know what happened........
Hugs!0 -
You are welcomepepebcn said:Thks cinnamon!
Hugs!
You are welcome pepebcn..........always good to read about such a promising new treatment !0 -
Hi,
Rick and I just got back
Hi,
Rick and I just got back from meeting with his HIPEC surgeon. I had asked him if he had heard of any new upcoming drugs at any of his recent conferences. He told us that there were several in Phase III trials that looked promising, but nothing major yet. So how very nice to open this post and see this news! :-) Thank you very much for posting about this new drug - it gives us all some hope. All my best, Cynthia0
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