Regorafenib do you know when is going to be approved by FDA?
Hugs!
Comments
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Dear Pepe
I had never heard of this drug, but so very glad you asked about it.
Here are two of many links I found from Oct. 2011:
http://www.prnewswire.com/news-releases/phase-3-trial-of-investigational-compound-regorafenib-in-metastatic-colorectal-cancer-meets-primary-endpoint-of-improving-overall-survival-132598538.html
http://www.medicalnewstoday.com/articles/236730.php
Apparently is hasn't been approved, yet, by the FDA but it has been put on Orphan status to encourage additional testing and also has been put on fast track reviews.
It sounds very promising and I certainly hope for all of us that approvals are very very soon!
Hugs,
Marie who loves kitties0 -
Thks Marie!Lovekitties said:Dear Pepe
I had never heard of this drug, but so very glad you asked about it.
Here are two of many links I found from Oct. 2011:
http://www.prnewswire.com/news-releases/phase-3-trial-of-investigational-compound-regorafenib-in-metastatic-colorectal-cancer-meets-primary-endpoint-of-improving-overall-survival-132598538.html
http://www.medicalnewstoday.com/articles/236730.php
Apparently is hasn't been approved, yet, by the FDA but it has been put on Orphan status to encourage additional testing and also has been put on fast track reviews.
It sounds very promising and I certainly hope for all of us that approvals are very very soon!
Hugs,
Marie who loves kitties
Hugs!0 -
Was wondering, too, aboutyoga said:thanks
Thanks Pepe for making note of this and thanks Marie for the links. Something else I will be asking my onc about when I see him next week. Let's keep our fingers crossed that approval comes along soon!
yoga jo
Was wondering, too, about how it works. Hope it is something different from Erbitux and avastin. I saw on another site, it could be the end of this year when it could possibly be available. They thought that would be the earliest.0 -
Pepe et al: phase III data on Regorafenib (Bay73-4506)geotina said:Pepe:
From what I have read of this drug, it did very, very well in trials thus they terminated the trials to get it "fast tracked" thru the FDA for approval. Last infomation I read on it was on the Colon Cancer Alliance site.
Take care - Tina
and mCRC is to be presented Jan 21 in San Fran at the Gastrointestinal Cancers Symposium of ASCO.....Read this two minutes ago, 11:24 AM, NY time......0 -
For some further info on trials in US (K-Ras/Braf mutation)coloCan said:Pepe et al: phase III data on Regorafenib (Bay73-4506)
and mCRC is to be presented Jan 21 in San Fran at the Gastrointestinal Cancers Symposium of ASCO.....Read this two minutes ago, 11:24 AM, NY time......
http://clinicaltrials.gov/ct2/show/NCT012985700 -
Thks Steve!coloCan said:For some further info on trials in US (K-Ras/Braf mutation)
http://clinicaltrials.gov/ct2/show/NCT01298570
Hugs!0 -
News of trial being reported in various press releases:pepebcn said:Thks Steve!
Hugs!
thestreet.com/story/11378552/1/onyx-colon-cancer-drug-juggles-survival-benefit-with-severe-serious-side-effects.html
or
medicalxpress.com/news/2012-01-drug-survival-colorectal-cancer-patients.html
or
medicalnewstoday.com/article/240428.php
among other sites0
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