Promising results for new drug

sasjourney

I just read an article about promising results from a phase three study for Bayer's drug Regorafenib. Trial has been stopped because positive results are showing. Complete clinical data should be released soon. Check out this link:

http://www.medpagetoday.com/Gastroenterology/ColonCancer/29286

There is always hope...

Hugs,
Sara

coloCan

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

Buckwirth

coloCan 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

The study
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.

Liz2011

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

pepebcn

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

How long can it takes to be approved by FDA?
Do they say anything about when is going to be in the market?
Hugs!

Buckwirth

pepebcn 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!

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.

cinnamongirl56

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

cinnamongirl56

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........

tanstaafl

coloCan 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

Take the money and run
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.

pepebcn

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.

As per I have seen EMEA is always a little bit late than FDA.
Hugs Buck.

pepebcn

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........

Thks cinnamon!
Hugs!

cinnamongirl56

pepebcn said:

Thks cinnamon!
Hugs!

You are welcome
You are welcome pepebcn..........always good to read about such a promising new treatment !

LivinginNH

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, Cynthia